MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Catalog Number	00588005012
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Approximately 6 months post-op, the patient was revised due to the locking screw backing out.The poly was revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.G2: foreign country: france.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
His follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d1; d2; d4; g1; g3; g4; g6; h1; h2; h4.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h6 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified a left total knee arthroplasty with hinged modular components.There is disassembly of the components at the hinge post mechanism and the hinge extension pin is displaced in the lateral soft tissues.The tibial is laterally displaced in relation to the femur and polyethylene insert.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified signs of use (dings, scratches) and is worn confirming complaint the threads are damaged but unable to confirm if reason backing out.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Medical records were provided and reviewed by a healthcare professional.Review of the records state that a patient subsequently underwent a revision left total knee arthroplasty where the rhk poly insert was revised/replaced, while the femoral component, tibial component, and gentamicin cement were retained; the screw was also listed as explanted.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: 12MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23335048
• Report Number: 0001822565-2025-03785
• Device Sequence Number: 9948982
• Product Code: JWH
• UDI-Device Identifier: 00889024199361
• UDI-Public: (01)00889024199361(17)281024(10)66255334
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 03/26/2026

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 Catalogue Number: 00588005012
• Device Lot Number: 66255334
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 12/04/2025; 12/03/2025; 03/26/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/09/2025; 12/29/2025; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male