MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS CEMENTED PRECOAT PATELLO-FEMORAL TROCHLEA COMPONENT RIGHT 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.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 is reported that the patient underwent a partial knee arthroplasty revision to address unknown complications post-operatively.Attempts have been made, however, no additional information is available.
Event or Problem Description
It is reported that the patient underwent a partial knee arthroplasty revision to address disease progression of osteoarthritis approximately four (4) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d4, d6a, g3, g4, g6, h2, h4, h6, h11.The reported event could not be confirmed as medical records were not provided.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Disease progression of osteoarthritis can continue in native bone structures as a patient continues to age.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patient¿s risk for progressive osteoarthritis.Additional trauma from external forces also accelerates this reaction.Patients with disease progression of osteoarthritis in the affected joint develop pain and decrease in joint flexibility.The root cause of the reported event was determined to be unrelated to the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GENDER SOLUTIONS CEMENTED PRECOAT PATELLO-FEMORAL TROCHLEA COMPONENT RIGHT 3
• 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: 24444236
• Report Number: 0001822565-2026-00613
• Device Sequence Number: 10364131
• Product Code: JWH
• UDI-Device Identifier: 00889024205864
• UDI-Public: (01)00889024205864(17)310309(10)11024953
• 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: 2026
• 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): 03/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00592601302
• Device Lot Number: 11024953
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2021
• 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 Sex: Unknown