Depuy bone cement recall DePuy Synthes is a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998. Product Classification Orthopedic Devices Device Class 2 This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. 5 bar according to the manufacturing process specification, mps-hpc006 rev u. Product Description : Antibiotic Simplex Bone Cement with Erythromycin/Colistin is packaged in two sterile components. 700 ORTHOPAEDIC DRIVE: Recalls: CDRH Recalls - - and transfer of bone cement into a suitable application or delivery system. , to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). The surgeons said they “encountered a high rate of debonding of tibial implant-cement interface,” with 21 complaints in the last two months alone. CMW1 is a medium/high viscosity cement for digital application CMW2 is a rapid set cement suitable for the acetabular cup via digital application. Bone cement: A mixture formed by the chemical reaction of two chemical agents (a monomer and a polymer) that produces a grout-like material that is used for some joint The DePuy Ceramax® Ceramic Total Hip System is a ceramic-on-ceramic bearing total hip replacement prosthesis system. Investigation summary : no device associated with this report was received for examination. 0 Introduction The survivorship of Total Knee Replacement (TKR) is dependent on, among other factors, the cementing technique used. Any DePuy SmartSeal pressurisers that have a To characterise the dosimetric impact of the presence of the DePuy CMW 1 bone cement, percentage depth-dose profiles (PDDs) were simulated using the BEAMnrc/DOSXYZnrc Monte Carlo (MC) user codes for EGSnrc , , for a 6 MV 10 × 10 cm 2 field produced using a validated Varian iX Clinac model , . 574-267-8143: Manufacturer Reason 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. Refer to the corresponding instruction for use regarding indications, contraindications, compatibility, use, precautions, warnings and side effects of the The DePuy CMW 1 Bone Cement is a high viscosity medium-setting time bone cement relative to other DePuy Synthes PMMA cements. Notifications were sent to consignees with the Device Classification Name: Bone Cement, Antibiotic: 510(k) Number: K061144: Device Name: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT: Applicant JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. 5mm Variable Angle Bone cement is an epoxy used to attach the components of a knee implant to human bone during a total knee replacement (TKR). Its proven clinical use has been demonstrated by more than 40 million procedures worldwide. DePuy CMW 2 is designed for digital application to small joints such as the knee patella and the hip DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. Also useful in stabilisation of vertebral fractures/luxations. I ask the doctor office staff to request a copy of Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. In a clinical setting, cemented hip stems are fixed in position with bone cement with approximate density and Young's modulus of 1. DePuy Orthopaedics, Inc. depuy orthopaedics’ fast-set cements can help surgical teams maximize efficiency and potentially reduce oR time. Type of Device: BONE CEMENT : BONE CEMENT. of units Material(s) Medical Device Product Recall (Removal) – Ref. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Device Damaged Prior to Use (2284) Patient Problem No Clinical Class 2 Device Recall DePuy CEMENT RESTRICTOR , Size 1: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1686-2011: Recall Event ID Sterile, DePuy Orthopaedics. , hip replacement, Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Missing At least four product liability lawsuits have been filed in the wake of Johnson & Johnson’s DePuy ASR hip recall that was announced last week. 3 Failure for the cement-implant interface may be due to the poor Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. SMARTMIX™ Bone Cement Mixing Systems; SMARTSET™ Bone Cement and DePuy CMW™ Bone Cement; Power Tools. . Type of Device: BONE CEMENT : Patient was revised to address loosening of the tibial component at the cement to implant and bone to cement interface. 3 The manufacturer has initiated the recall and not all Device Recall DePuy CEMENT RESTRICTOR , Size 1. Clips. They come in a variety of sizes (length and diameter) Recall History devices via the 510( k) pathway with bone cement as the method of fixation. DePuy developed and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. Field Safety Notices about DePuy CMW2 Gentamicin Bone Cement According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field DePuy Orthopaedics, Inc. We present 7 patients implanted with 8 TKAs with clinical failure and a cement hypersensitivity diagnosis. The knee implant lawsuit says the DePuy SmartSet HV bone cement used in the plaintiff’s replacement surgery was a high viscosity cement. One such brand is DePuy, a subsidiary of the Johnson & Johnson pharmaceutical empire. As knee replacement has become a much more common solution to knee problems in younger patients, those (particularly those with pre-existing heart problems) may face an increased risk developing bone cement implantation syndrome. , 325 Paramount Dr, Raynham MA 02767-5199 Manufacturer Parent Company (2017) Johnson & Johnson Source USFDA 4 devices with a similar name bone cement retentions confidence spinal cement system 7cc kit, confidence spinal cement system 1 Model / Serial Manufacturer Explore more than 120,000 Recalls, Safety Alerts and Field Safety Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1764-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity Orthopaedic bone cement restrictor instrumentation. Clip Appliers. Bone Cement (3) Cages and Spacers (10) Instruments (2) Personalization and Planning (1) Plates and Screws (4) Power Tools Small Bones (2) Retractors (2) A 6. Wash the area with detergents and water, Bone Cement: 510(k) Number: K033563: Device Name: SMARTSET GHV GENTAMICIN BONE CEMENT: Applicant: DEPUY ORTHOPAEDICS, INC. 4-5 minute mark. Competitor products were implanted with two depuy cement products. Article number Article name 07. Military Veteran Advocacy. Circular Staplers. If the bone cement chips or the cement’s bond breaks with the bone, the aseptic loosening can result in a host of problems. The FDA began investigating DePuy CMW 1 bone cement after receiving an Adverse Event Report in September 2012. 19 In vitro studies have shown that applying cement to both the under-surface of the tibial tray and onto the tibial bone leads to optimal cement penetration. Indications that DePuy CMW-1 bone cement may have failed to remain attached to the bone The patient was revised due to tibial tray collapsed medially. 4 Clinical Results DePuy CMW 1/DePuy CMW 1 Gentamicin: More Than 40 Years of Clinical Experience DePuy CMW 1 bone cement has the longest clinical heritage of any orthopaedic bone cement. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 9616671 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Adverse Event Without Identified Device or Use Problem On (b)(6) 2014 patient received a left attune total knee to treat oa. CMW3 is a more fluid cement which is more appropriate Orthopaedic bone cement restrictor instrumentation. Depuy cement manufacturer was used. Should additional information be Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 3: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1689-2011: Sterile, DePuy Orthopaedics. 17 E. This device is intended to restrict bone cement migration into the distal DePuy – Attune Revision Tibial Insert, various sizes Attune Revision Tibial Insert (various sizes) received a higher than specified irradiation dose. 16, 2015. It provides a reliable working time for modern cementing techniques with a setting time of approximately 12. 1988: 5 Pro Osteon ® Implant 500 Hydroxyapatite Bone Void Filler: P860005: Interpore Intl. News & Press. Founded in 1895 by chemist and pharmaceutical salesman Revra DePuy, DePuy was the world's first orthopaedics company. 0 Introduction The survivorship of Total Knee Replacement (TKR) is at the cement-bone interface may appear as radiolucent lines and is usually attributed to poor penetration of the cement into the bone. Manufacturer (Section D) DEPUY: MDR Report Key: 4603943: MDR Text Key: 5695722: Report Number: ComparedTo Other Depuy Synthes Bone Cements,Depuy Cmw 2 Bone Cement ProvidesRapid Working Time For Efficient Surgery. I discovered that there were knee replacements that had been on recall, etc. S. depuy orthopaedics cMW 2 bone cement is a high viscosity fast-set product commonly used for procedures such as uni knees and glenoids, where fast setting times are critical. Almost all significant problems necessitate revision surgery. Aseptic loosening is when the device moves out of place without The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DePuy CMW Bone Cement Designed for total hip replacement. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DEPUY ORTHOPAEDICS INC US SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number underwent a primary right knee arthroplasty to treat severe arthritis. 2293230 Product Subject to this Removal: Part Number Part Description Lot GTIN 1504-01-204 ATTUNE CR Femoral Right Size 4 Porous 3883327 10603295041474 Dear Surgeon, By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the Device Recall DePuy CEMENT RESTRICTOR, Size 5 Model / Serial Product Code 546018000, Lot ET5EW4, Size 5. penetrate the surgical site, and remain inside the patient without the surgeon’s awareness. 2. Device Recall DePuy Cement, bone, vertebroplasty - Product Code NDN: Product: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. This device is intended to restrict bone cement migration into the distal medullary canal during implantation Cementing technique has been shown to be important for long-term implant survival. Manufacturer: DePuy Spine, Inc. 700 ORTHOPAEDIC DRIVE: WARSAW, IN 46581 -0988 Applicant Contact: TIFFANI D ROGERS: Correspondent: DEPUY ORTHOPAEDICS, INC. There are many brands that manufacture bone cement that has unfortunately been linked to failure or sometimes BCIS. All 7 patients also showed hypersensitivity to metal, most commonly Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3092-040: Device Problem Adverse Event Without Identified Device or Use Problem Device Recalls Device Safety Communications GUDID Advanced Search; Search Help; Home; About; News; API; Download; Help; View More DEPUY (IRELAND) Primary DI Number: 10603295174295 Issuing Device Description: Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g CLOSE. 1997: 9: Bone graft and filler Alveoform™ Biograft: P860012: Collagen Corp. The other side of the tibia was clean. 040S TRAUMACEM V+ Bone Cement, injectable Description TRAUMACEM V+ Injectable Bone Cement consists of sterile packed compo - nents to create radiopaque TRAUMACEM V+ Injectable Bone Cement. Femur, tibia & insert along with depuy bone cement were removed. They come in a variety of sizes (length and diameter) Bone cement implantation syndrome, or BCIS, is a severe complication of knee replacement surgery. , Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and AAP Implants Inc. The notification described the product, problem and actions to be taken. Several studies have described good short-term outcomes; however, there have been reports of early failures due to tibial baseplate debonding at the implant-cement interface of The ATTUNE Knee System (DePuy Synthes, West Chester, PA). Clinically the knee didn¿t look infected. Brands Associated with Bone Cement Failure. This is within the specification of 151. CMW is the industry standard. Cement was mixed as per proper technique, the cement had been housed in the theatre for preceding 3-4 hours and theatre temperature was 18. 5-188. Examine your inventory The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis. No complications were noted. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. 5 minutes at 19°C 4. This can lead to oxygen deficiency, embolism, heart attacks and in some cases, death. " Improperly mixing the cement can lead to the artificial knee device failing to adhere to the bone and also can cause infections. Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Bone cement failure typically occurs for one of two reasons: either aseptic loosening or bone cement implantation syndrome. There was no surgical delay. Its companies form part of the Johnson & Johnson Medical Devices Group. 1 degrees c. Manufacturer Narrative The defendants include Depuy Synthes Sales Inc. Water was however found slowly leaking behind the Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of 2 DePuy Synthes fiGuidance for Cementing Primary TKR Cementing Total Knee Replacements 1. Frank filed his lawsuit in October 2018 against DePuy, Johnson & Johnson, Stryker Corporation, Howmedica, and Aap Implants Inc. Main Street Suite 200 Pensacola, FL 32502 (844) 794-7402 (850) 202-1010. Free Shipping on Purchases Over $100 | Use Code TAKE5 for 5% OFF DePuy SmartSet Bone Bone Cement. For information on compatibility with other devices or systems, consultation with a DePuy Synthes representative is recommended. SMARTSET Bone Cements are the latest cements in the DePuy Synthes portfolio. Model / Serial Product Code 546010000, Lot ET5DV4, Size 1. There were no indicated intra-operative complications. A new rp poly was implanted as Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1775-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problem Difficult to Open or Remove Packaging Material (2922) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: ENDURANCE BONE CEMENT 40G. SmartsetBone Cements Are The Latest Cements In The Depuy Synthes Portfolio. 1984: 6 DePuy 1 Bone Cement: P960001: DePuy Orthopaedics Inc. 5 minutes at 19°C (66°F). all lot numbers are affected by this recall. Based in Warsaw, Indiana, the company Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 5: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1690-2011: Sterile, DePuy Orthopaedics. Any DePuy SmartSeal pressurisers that have a For more than 60 years PALACOS ® has been successfully used in arthroplasty for effective and permanent fixation of implants in bone. Manufacturer DePuy By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the ATTUNETM Cementless CR Femurs listed in the above table. 2 (Liquids, SmartSet) Date: 8 May 2014 Supersedes: May 2011 Page 4 of 9 6. , many of them Authorized Wholesale Dealer of Bone Cement - DePuy CMW Heritage Bone Cements, Stryker Surgical Simplex P Bone Cement, Antibiotic Bone Cement and Biocompsites Stimulan Rapid Cure offered by Divine Surgical, Chandigarh. Type of Device: CEMENT. The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon 2 DePuy Synthes SMARTSET ™ Bone Cements Product Information INTRODUCTION Our experience in PMMA bone cements is extensive. The Attune Knee lawsuits being filed against DePuy Synthes claim the medical device was defectively designed so that surgical glue would not properly hold the device to the patient’s tibia bone. ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6: Arthroplasty: 3/29/24: K202194 ; K213781 ; K232303 Implants have a central cavity that allows them to be packed Acrylic bone cement is the most common method of fixation for primary total knee arthroplasty (TKA). The ATTUNE S+™ Technology is yet another way that DePuy Synthes is driving evidence-based innovation intended to make continuous enhancements with the goal of positively affecting patient outcomes and Product Information: SmartSet HV Bone Cement, 40G, High-Viscosity Manufacturer Part # 3092-040 Description Developed to meet the needs of today's orthopedic surgeons Medium viscosity for a less doughy consistency HPIS Code 550_17_0_0 Latex Free Yes UNSPSC 42. Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in DEPUY CMW 9619821 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3312-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 1 40G. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Manufacturer (Section D) DEPUY IRELAND - Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Patella baja was noted and was corrected Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284) The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. WARSAW, IN 46581-0988: PMA Number TRAUMACEM™ V+ System is a polymethylmethacrylate cement for augmentation of a trauma device that allows injection of a controlled amount of cement into a femoral head. The plaintiff points out that the defendant originally received FDA clearance for their product through the FDA’s 510(k) notification process, which means that the defendants did not have to go through the comprehensive The complaint acknowledges contributions from the several medical journals that indicate that HV bone cements including the DePuy bone cement known as SmartSet HV are causing components of otherwise well-reviewed knee prosthetics to become loose or even disassociate from the bone. C. Over 700,000 knee replacement surgeries are performed each year in the U. DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3) Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Defective Bone Cement. It is intended for treatment of osteoporotic fractures of the upper and lower extremities in combination with DePuy Synthes fixation devices intended for Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 3015516266 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3312040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Class 2 Device Recall DePuy: Date Initiated by Firm: June 29, 2022: Create Date: July 20, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-1419-2022: Recall Event ID: 90557: Template - Product Code HWT: Product: ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral Bone Cement (4) Cages and Spacers (11) Cartilage Restoration. 1 Among Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY ORTHOPAEDICS INC US DEPUY CMW 2G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3325040: Device Problem Chemical Problem (2893) Patient Problem Insufficient Information 2 DePuy Synthes fiGuidance for Cementing Primary TKR Cementing Total Knee Replacements 1. The SynJect Cement Delivery System is intended for the application of DePuy Synthes PMMA-based bone cement, Vertecem V+ Cement Kit, with the intent to augment cancellous bone. The pump was tested with a pressure gage to ensure output of the correct pressure. Available In Medium And High Viscosity Formulations, With And WithoutGentamicin, Smartset Bone Cements Were Developed To Meet TheNeeds Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 ENDURANCE BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3070040: Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284) D G Enterprise - Offering Depuy Smartset Gentamicin Bone Cement, Model Name/Number: 3092-040 at ₹ 2600/piece in Ahmedabad, Gujarat. Center for Leadership. DEPUY IRELAND - 9616671 DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Loss of or Failure to Bond (1068) Patient Problem Insufficient Information (4580) Event Date 03/13/2023: Event Type Injury Event Description The patient was revised due to tibial tray collapsed medially. Product complaint # (b)(4). Should additional information be It was noted that the reservoir was filled with dried cement. The ATTUNE™ Cementless Total Knee System is intended for cementless use within the ATTUNE™ Total Knee Replacement System. g. Four quantities of depuy cements were used. 7/3. It Was Anticipated That AShorter Pressurization Time Would ReduceThe Risk Of Movement Whilst Waiting ForThe Cement To Set. DePuy Orthopaedics, Inc. 3027: Applicant: DEPUY, INC. DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-35-500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) including depuy patella were utilized along with depuy cement x2. F. || SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric Wholesaler of Bone Cement - Depuy Smartset HV Bone Cement, Depuy CMW 1 Bone Cement, Palacos R Bone Cement and Surgical Simplex P offered by Y K Surgicals, New Delhi, Delhi. DePuy SmartSeal™ pressuriser: femoral and acetabular pressurisers (5 pack) for use with orthopaedic bone cement. Depuy considers the investigation closed. While using the cement, it appeared to go off (hard) quicker than expected (at approx. DePuy SmartSet Bone Cement – Liquid Component Version 2. 20 Other in vitro studies have demonstrated that cement applied to the tibia and the keel increases pull-out strength DEPUY ORTHOPAEDICS INC US DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577) Event Date 02/10/2022: Event Type Injury Event Description Search As part of Johnson & Johnson, DePuy continues to innovate. Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. Recalled models include the LCS Knee Implant-Meniscal bearing insert (2008, mislabeling); the LCS Duofix Femoral Component (an Device: DEPUY 1 BONE CEMENT: Generic Name: BONE CEMENT: Regulation Number: 888. Affected side: right knee. Arthroplasty Products. 5 minutes at 65 degrees f, depuy orthopaedics cMW DePuy Spine, Inc. DePuy Ireland is initiating a medical device recall (removal) of one lot of the ATTUNE™ Cementless CR Femurs listed in the above table. When an implant loosens without concurrent infection, the result is known as aseptic loosening. It Was Developed To Have A ShorterSetting Time And Thus Increase EfficiencyOf Surgery. DePuy is a For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. The patella was resurfaced and cement mfg is depuy. We examined Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; DePuy has also faced recalls and warnings for other surgical and joint replacement devices including surgical tools and hip replacements. There was loosening at the bone/cement interface. Please refer to Table K863528 DEPUY BICONDYLAR TOE PROSTHESIS DEPUY, INC. (sticker sheet page 276 of 570). The patient¿s knee also felt unstable and weak. 3 Failure for the cement-implant interface may be due to the poor Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2103-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. The femoral component, tibial component and tray were removed and attune revision was put in. Unfortunately, these high viscosity bone cements The Urgent recall notice described the recalled product, explained the reason for the recall, and directed consignees to cease further distribution, complete the attached Reconciliation form and quarantine and return all affected products through the DePuy Orthopaedics Sales consultant, Fax 1-787-287-7681 or Email to vbaez1@its. The pumped maxed at 179. DePuy Knee Implant-Related Recalls These instruments were meant to help surgeons position the Stryker Triathlon knee implant DEPUY ORTHOPAEDICS, INC. Cm2 cement was used. Type of Device: BONE It was reported that a part of the secondary packaging polyethylene bag containing powder of the cement (p/n: (b)(4)) had already been distorted when it was opened for using during the tka surgery on (b)(6) 2019. It may also be intended for use as a filler in the case of bone pathologies (e. The FDA described the product as "A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. The procedure was completed without complications. DePuy Knee Replacement Complications. About the database; How to use the database; Download the data; FAQ; Credits; Events. CMW1 is a medium/high viscosity cement for Class 3 Device Recall SIMPLEX Bone Cement with Tobramycin: Date Initiated by Firm: November 07, 2022: Date Posted: December 20, 2022: Recall Status 1: Open 3, Classified: Recall Number: Z-0737-2023: Recall Event ID: 91147: 510(K)Number: K014199 : Product Classification: Bone cement - Product Code LOD: Product: Tobra Full Dose CE Antibiotic Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1769-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity DePuy has admitted that "knee implants are known to fail at the cement-bone interface or at the cement-implant interface. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Gentamicin DePuy They found that all 15 patients had loose components in the knee — and no bone cement bonding the tibial baseplate to the bone. Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement. Doi: (b)(6) 2021. Manufacturer Depuy Orthopaedics, Inc. Class 2 Device Recall DePuy P. Acrylic bone cements for vertebroplasty Bone Cements: Formulation, Modification, and Characterization 1055 Cementing Total Knee Replacements 1. Porous coated implants may be used with or without cement. Investigation summary: no device associated with this report was received for examination. DePuy CMW-1 Bone Cement Problems. 1 Early attempts to use acrylic cement in orthopaedic surgery may have failed due to a misunderstanding around how the cement functions. This would prevent the reservoir from being loaded correctly and a new set would Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2102-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral DePuy Synthes offers an innovative spine portfolio that includes products designed to address the most complex and challenging cases in spine surgery. 3 bar before the safety valve engaged. This exceeds the validated Recall of DePuy CMW 2 Gentamicin Bone Cement 20 g According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced > The FDA has classified a voluntary recall by Johnson & Johnson ($JNJ) business DePuy Synthes of its Smartset GHV Gentamicin, a bone cement containing antibiotics, as a DePuy Orthopaedics, Inc. 1992: 1 Collagraft Bone Graft The Long ClinicalHeritage Of Our Depuy Cmw™ Bone Cement Product Range Has AllowedUs To Evaluate And Refine The Product Range Over Time. About Recall Status 1: Terminated 3: Recall Number: Z-0064-2014: Recall Event ID: 66248: SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin A DePuy Sigma knee replacement system was used during her surgery, which was affixed using DePuy Cement. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). In 2016, DePuy announced “new clinical evidence of the In other cases, the toxic ingredients contained in DePuy CMW 1 bone cement leech into the patient’s tissues and blood vessels. after allegedly suffering complications following his knee replacement surgery in 2015. D Device Description: SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (023012) and its similarity in indications for use to DePuy 1 Gentamicin Loosening can result in bone fractures, instability, and catastrophic falls. 07. DePuy ASR Hip Recall; DePuy Attune Knee Replacements; Depuy Curved Condylar Plate; DePuy Hips; DePuy Orthopaedics Hip Replacements; DePuy Synthes SimartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. from publication: Influence of HRGO Nanoplatelets on Behaviour and Processing of PMMA Bone Cement for The AAOS Device Recall Dashboard provides orthopaedic surgeons with timely recall information that will protect the health and well-being of their patients. With a setting time of 6. 3 Methods and materials for containment and clearing up Clean up small spills of less than20 ml through use of absorbent material and dispose of contaminated material as hazardous waste. What MRI Patient was revised due to arthrofibrosis. 5mm Midfoot Fusion Bolt for osteotomies and other large bone Depuy International Heraeus Kulzer Stryker-Howmedica-Osteonics Zimmer Inc. 016S Vertecem V+ Cement Kit Material(s) Containers for storage, transport and use: Container No. Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. , Depuy Orthopaedics Inc. All demonstrated hypersensitivity to bone cement via skin patch and/or lymphocyte transformation testing. The FDA Recalls Depuy's LPS Diaphyseal Sleeve | 4/13/2018; DePuy Knee Replacement DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-32-500: Device Problem Loss of or Failure to Bond (1068) Patient Problem Insufficient Information (4580) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY/CMW 2G. Depuy Cmw 3 Is A Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Also find Bone Cement price list | ID: 20011537791 Product complaint # (b)(4). 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Gentamicin DePuy The resin was consequently left for 24 h to solidify completely. the intended use stated in the ifu for the smartset¿ gmv endurance DePuy (a subsidiary of Johnson & Johnson): 477 recalls (4 class I; 470 class II; 3 class II). com. one of which was the NexGen CR Knee System from Zimmer Biomet, which was subject to a Class 2 Recall in January 2016. On (b)(6) Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3332-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) DePuy CMW 1 Bone Cement; Stryker/Howmedia Simplex HV Bone Cement; DePuy SmartSet HV Bone Cement; Biomet/DJO Surgical Cobalt HV Bone Cement; How to Recover Compensation for Bone Cement: Mass Tort. According to one report, a number of orthopedic surgeons have Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. In June 2015, DePuy issued a Class II recall for approximately 3,274 units of Product complaint # (b)(4). UNIUM™ System; Battery Power Line II; Trauma Recon System; ACRION™ Saw Blades; Compact Air Drive II (CAD II) Electric Pen Drive; Piezoelectric System; Shoulder and Elbow. jnj. Sigma Knee System; Free Case Evaluation. Product Information: SmartSet MV Bone Cement, 40GManufacturer Part # 3122040Description Developed to meet the needs of today's orthopedic surgeons Medium viscosity for a less doughy consistency HPIS Code 550_17_0_0 Latex Free Yes UNSPSC 42296702 DePuy SmartSet Bone Cement - Bone cement Palacos ® R Bone Cement: P810020: Smith & Nephew Richard, Inc. Previous Cases. Continuous Compression Implants (1) Curved Cutter. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: DePuy Synthes Sales Consultant. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Device Characteristics. 3 packs (120g) cement were opened during the surgery, and one of which had been partially deformed. Drillable Bone Void Filler is a calcium phosphate cement with collagen for use in bone fracture repair procedures. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 545032500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); No Code Available (3191) Event Date 01/23/2019: Event Type Injury Manufacturer Narrative Search DEPUY BONE CEMENT: Back to Search Results: Model Number 3102-040: Device Problem Insufficient Information (3190) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: BONE CEMENT. Medium Viscosity Antibiotic Bone Cement, Sterile. Affected side: left knee. On (b)(6) 2020 patient underwent a left knee revision due to pain and discomfort. The plaintiff says he was was Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3092040: Device Problem Adverse Event Without Identified Device or Use Problem The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). The femoral Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. However, by May of the same year, she began complaining of extreme pain down her right knee DePuy Orthopaedics, Inc. Various options are available. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. FDA Recalls of DePuy Knee Replacement System | 4/27/2018; DePuy Knee Replacement Systems and At 19°C (66°F) DePuy CMW3 bone cement sets approximately after 12 ½ minutes. , a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002) cases such as mine with a total knee replacement. 702. DePuy CMW 1 Bone Cement; DePuy SmartSet HV Bone Cement; Stryker/Howmedia Simplex HV Bone Cement Download scientific diagram | Composition of DePuy Ibérica CMW 1 bone cement radio-opaque. A new tibia (stemmed) with augments was re-implanted. Depth-dose profiles were simulated using four phantom geometries: Catalog NOs. The tibia was removed without difficulty. Between 2003 and 2013, DePuy issued at least 200 knee replacement-related recalls. 700 ORTHOPAEDIC DR. 8M; The company first issued recall letters in early February due to partial agglomeration of one lot that could require surgeries to be delayed. Letter states reason for recall, health risk and action to take: 1. 4 The confidence 11cc spinal cement system was not returned for evaluation. The cases, which allege that the metal-on-metal hip Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number: Z-1768-2011: Recall Event ID: 57177: 510(K)Number: K032659 : The femoral resurfacing heads have a polished exterior surface and an internal cavity Orthopaedic cement, antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint Little is known about patients with bone cement hypersenstivity after total knee arthroplasty (TKA). However, based on the complaint what most likely happened was that the surgeon connected the cap to the reservoir before transferring cement, which would cause the plunger to be in the empty cement reservoir. Available in medium and high viscosity formulations, with and without Gentamicin, SMARTSET Bone Cements were developed to meet the needs of Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e. The system consists of five parts: o Femoral Head The FDA’s database shows at least six other DePuy knee replacement recalls since 2013. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. The tibia had cement/bone remaining on one side. One component is an ampoule containing 10ml, or 20ml of a colourless, flammable liquid monomer that has a sweet slightly acrid odour and contains Methyl methacrylate (monomer), N,N-dimethyl pare toluidine and Hydroquinone. Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 4: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Terminated 3 on April 23, 2013: Recall Number: Z-1687-2011: Sterile, DePuy Orthopaedics. That’s more than any other knee implant manufacturer. Among the brands This item may require 1-2 days to ship out from our facility. The long clinical heritage of our DePuy CMW™ bone cement product range has allowed us to evaluate and refine the product range over time. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET GHV Gentamicin Bone SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or DePuy CMW™ 2 Bone Cement is our fast-setting high viscosity bone cement, setting in approximately 6. Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. 3, 5 Used by Sir John Charnley, who pioneered modern joint replacement, CMW 1 Bone Cement DePuy bone cement recalled; InspireMD raising $13. The DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. Dor: (b)(6) 2023. 2 Cement achieves a mechanical bond to the bone by DePuy CMW Bone Cement Designed for total hip replacement. 325 Paramount Dr Raynham MA 02767-5199: For Additional Information Contact: 508-828-3769: Manufacturer Reason for Recall: Cement mixer used to prepare cement for surgery may not Smartset ghv was used to cement an attune total knee using the smartset cemvac vacuum mixing system. DePuy Knee Implant Recall. Product Classification Orthopedic Devices Device Class 2 Implanted device? This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis Manufacturer Depuy Orthopaedics, Inc. The smartset¿ gmv endurance gentamicin bone cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the us fda. agcedm ldrfp qfytl uwusp lmg ybsqvh pgdxdgi pahj ltge sjy