MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT FEMORAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
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: updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The reported event was confirmed.Visual examination of the provided picture found the device to have signs of implantation as the device is coated in a foreign substance and the hinge post subcomponent to be fractured.As the device was not returned further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision surgical notes: implant breakage specify, revision right tka replacement with plastics involvement, the hinge pin broke 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
(b)(4).G2: foreign - event occurred in australia.D10: 66022663, palacos r + g (1x40), 98971042.20800000020, iassist pin & screw pack sterile, 65107668.Unknown, tibial component, unknown.Unknown, articular surface, unknown.H6: proposed component code: mechanical (g04) - femur.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 medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.After approximately 12 years, they had a revision due to unknown reason.No operative records provided.Then, about a year later the patient had a right knee exploration of extensor tendon and two years later the patient underwent a 2nd revision for implant breakage of the hinge pin.No further information has been provided.

• Brand Name: ROTATING HINGE KNEE CEMENTED OPTION FEMORAL COMPONENT FEMORAL
• 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: 23790425
• Report Number: 0001822565-2025-04485
• Device Sequence Number: 5712285
• Product Code: JWH
• UDI-Device Identifier: 00889024199132
• UDI-Public: (01)00889024199132(17)250915(10)64695390
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 01/26/2026

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 Expiration Date: 09/15/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001402
• Device Lot Number: 64695390
• Was Device Available for Evaluation?: No
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female