MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZUK PRC FEM SZD RMED/LLAT; PROSTHESIS, KNEE

Catalog Number	00584201402
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10- medical product zuk prc tray sz3 rmed/llat item# 00584200302 lot# 62925355.Zuk art surf sz3 8mm item# 00584202308 lot# 62742487.G2- australia.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Proposed annex g code: mechanical (g04) ¿ femur.
Event or Problem Description
It was reported that a patient was revised approximately ten years and six months post implantation due to metallosis and poly wear.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, g1, g3, g6, h1, h2, h3, h6, h10, and h11 visual examination of the provided pictures identified explanted tibial tray, femur and articular surface.The articular surface shows excessive wear, particularly on the edges.The devices show signs of use such as scuffs and scratches.X-rays were provided and reviewed by mmi state that a right knee medial compartment arthroplasty was identified.Varus alignment of the knee joint and narrow medial joint space consistent with wear or other compromise of the polyethylene bearing.Radiolucency medial femoral condyle is likely due to stress shield versus less likely osteolysis.Suprapatellar pouch radio dense synovial lining (metal-line sign) which is consistent with metallosis.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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: ZUK PRC FEM SZD RMED/LLAT
• 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: 24496469
• Report Number: 0001822565-2026-00696
• Device Sequence Number: 14697351
• Product Code: HSX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 00584201402
• Device Lot Number: 62867435
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2014
• 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 Sex: Male