MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE ART SURFACE 12MM FEM SZ F; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Catalog Number	00588006012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in germany.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or 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 on an unknown date.Subsequently, on an unknown timeframe post-implantation, the articular surface dislocated as the hinge pin came loose.The patient underwent revision surgery to replace the affected component.Due diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a4; b3; b4; b5; b7; d6; d10; g3; h2; h6; h11.D10: medical product: left size f cemented option femoral component: catalog#00588001601, lot#67072878; size 5 precoat cemented tibial component: catalog#00588000500, lot#66852435; 12mm diameter 100mm length offset stem extension combined length 145mm: catalog#00598802012, lot#67120539; trabecular metal femoral diaphyseal cone, 30mm, large, left: catalog#00545001930, lot#66362727; long 12mm diameter 155mm length straight stem extension combined length 200mm: catalog#00598801112, lot#65828896; trabecular metal tibial cone, medium 36x31mm: catalog#00545001336, lot#67037036; all poly petella standard cemented size 41 mm diameter 10.0 mm thickness: catalog#00597206541, lot#66635015; copay g+c cement: catalog#66017790, lot#ni.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty.Approximately five (5) months post-implantation, the coupled knee prosthesis had become uncoupled, resulting in knee dislocation.The axle bolt had disengaged from its retaining bushing, leaving the prosthesis unstable and easily removable.Subsequently, the patient underwent revision surgery to replace the articular surface.Due diligence is complete as multiple attempts have been made however all available information has been provided.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty.Approximately five (5) months post-implantation, the coupled knee prosthesis had become uncoupled, resulting in knee dislocation.The femoral, tibial, and retropatellar components were found to be well-anchored and intact however the axle bolt had disengaged from the retaining bushing.Subsequently, the patient underwent revision surgery to replace the inlay and loose axis without complication.Due diligence is complete as multiple attempts have been made however all available information has been provided.
Additional Manufacturer Narrative
Medical records provided and reviewed state that the patient underwent an initial left total knee arthroplasty with implants of unknown type.No medical records were available for this initial procedure.The patient subsequently underwent a first revision left total knee arthroplasty.The revision was indicated due to implant loosening, polyethylene wear, and extensive osteolysis, approximately two decades following the initial procedure.Manufacturer components were implanted at this time.Five months later, the patient underwent a second revision left total knee arthroplasty.The indication for this revision was dislocation because of minor movement.Intraoperative findings noted hematoma effusion and scar tissue, considered a normal finding at five months post-operatively.The loose axis and inlay were removed, while the femoral, tibial, and retropatellar components were found to be firmly anchored and intact.Trial components revealed laxity.The articulating surface was revised during this procedure, with all other components retained.Reported event was confirmed by review of provided medical records.Root cause was unable to 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.

• Brand Name: NEXGEN ROTATING HINGE KNEE ART SURFACE 12MM FEM SZ F
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• 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: 23874073
• Report Number: 0001822565-2025-04735
• Device Sequence Number: 12190526
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/21/2026

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: 00588006012
• Device Lot Number: 66867028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/09/2026; 09/11/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/04/2026; 03/16/2026; 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 264 LB