MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE 12MM HEIGHT SIZE C ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number	00588003012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: left size c cemented option femoral component: catalog#00588001301, lot#ni.G2: foreign - event occurred in germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately two (2) years and six (6) months post-implantation, the patient began to experience pain and restriction of movement.Diagnostic images revealed a fracture of the hinge pin.Subsequently, the patient underwent revision surgery to replace the affected components without reported complication.Due diligence is in progress for this event; to date all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g3; h2; h3; h4; h6; h11.Visual inspection of returned device exhibit signs of use (gouges) and confirms that the extension post is fractured.Performed dimensional analysis on hinge post extension and results are within specification.Further fracture analysis of the returned device suggests that the device possibly fractured due to fatigue mode of failure.Device history record was reviewed and no discrepancies related to the reported event were found.Review of the diagnostic x-rays by third party health care professional confirm fracture of the hinge post extension component, along with posterior dislocation of the tibia.Root cause was unable to be determined.Reported event was confirmed by review of radiographs and returned product evaluation.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 at time of this report.

• Brand Name: NEXGEN ROTATING HINGE KNEE 12MM HEIGHT SIZE C ARTICULAR SURFACE
• 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: 23572276
• Report Number: 0001822565-2025-04172
• Device Sequence Number: 18710253
• Product Code: JWH
• UDI-Device Identifier: 00889024199248
• UDI-Public: (01)00889024199248(17)270325(10)65306918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/05/2026

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: 00588003012
• Device Lot Number: 65306918
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2022
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 96 KG