MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X63/67; PROSTHESIS, KNEE

Catalog Number	183422
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee revision due to major poly wear and loss of tibial fixation.The presence of metallosis was noted.It was reported that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections were updated: b4; b5; d1; d2; d4; d9; g3; g4; g6; h1; h2; h4; h11.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10; h11.Visual examination of the returned products identified signs of implantation on the femoral implant, with surface scratches and foreign material adhered to the implant's surface.The articular surface has surface scratches and wear on a condyle.The tibial implant shows signs of use with scuffing and wear on the stem portion of the implant, no foreign debris was noted on the implant.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Visual examination of the provided videos found the knee to be unstable prior to the revision procedure along with the tibial plate loose enough from the bone cement to be able to remove by hand.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the right knee arthroplasty with osteolysis along the tibial implant as noted.No frank implant loosening.Implant fit and alignment are maintained.Bone quality is osteopenic.There is radiolucency along the tibial implant as noted.No evidence of implant loosening.A definitive root cause cannot be determined.The complaint was confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VNGD CR TIB BRG 12X63/67
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21944992
• Report Number: 0001825034-2025-01294
• Device Sequence Number: 12898570
• Product Code: JWH
• UDI-Device Identifier: 00880304271067
• UDI-Public: (01)00880304271067(17)221015(10)363840
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/15/2022
• Device Catalogue Number: 183422
• Device Lot Number: 363840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 09/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/22/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 141252: TIBIAL TRAY: 2012032179; 183006: FEMORAL COMPONENT: UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG