MAUDE Adverse Event Report: Zimmer Biomet, Inc. NexGen Rotating Hinge Knee Left Size F Cemented Option Femoral Component; Prosthesis, Knee

Catalog Number	00588001601
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a left total knee arthroplasty.Approximately two (2) years and two (2) months post-implantation, the patient sustained a torsional injury to the implanted joint, thus resulting in instability.Radiographic evaluation revealed displacement of the hinge mechanism indicating possible implant failure of the hinge assembly.Subsequently, the patient underwent revision surgery in which the femoral hinge post was found to be fractured.The affected components were replaced without reported complication.Due diligence is in progress for this event; to date all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: posterior femoral augment block precoat size f 5 mm augment with screw: catalog#: 00599003601; lot#: 64516927; distal femoral augment block precoat size f 10 mm augment with screw: catalog#: 00599003620; lot#: 64716294; qty# (b)(4); posterior femoral augment block precoat size f 10 mm augment with screw: catalog#00599003602; lot#64200187; tibial full block augment precoat size 6 10mm thickness: catalog#: 00588000610; lot#: 64973933; trabecular metal tibial cone; medium 31x31mm; catalog#: 00545001331; lot#: 65512476; trabecular metal femoral diaphyseal cone, 30mm, small, left: catalog#: 00545001730; lot#: 66362719; size 6 precoat cemented tibial component: catalog#: 00588000600; lot#: 65091872; 15mm diameter 100mm length straight stem extension combined length 145mm: catalog#: 00598801015; lot#: 65152108; 16mm diameter 100mm length straight stem extension combined length: catalog#: 00598801016; lot#: 65959358; all poly patella standard cemented size 35mm diameter 9.0mm thickness: catalog#: 00597206535; lot#: 66673129; 12mm height size f articular surface with hinge post extension: catalog#00588006012, lot#: 65049626.G2: foreign: germany h6: proposed component code: mechanical (g04) - femur.Diligence is in progress to determine whether the device is available for further evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: NexGen Rotating Hinge Knee Left Size F Cemented Option Femoral Component
• 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 ; +1(574)526-0384
• MDR Report Key: 50284027
• Report Number: 0001822565-2026-02885
• Device Sequence Number: 10068587
• Product Code: JWH
• UDI-Device Identifier: 00889024199163
• UDI-Public: (01)00889024199163(17)290331(10)66283682
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 00588001601
• Device Lot Number: 66283682
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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 Age: 33 YR
• Patient Sex: Male