MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING (PS) LEFT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512400810
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) g2: united arab emirates.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.
Event or Problem Description
It was reported that a patient was revised approximately three years three and a half months post implantation due to pain, instability, poly wear and implant fracture.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information 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, and h11.Visual inspection of the provided image performed.Item and lot number marked on the device confirmed as correct.The images clearly show that part of the device has fractured away into separate pieces.The main body of the device itself also appears to show signs of use with wear around the edges.Unable to perform fracture analysis from the provided images as the view of the fractured surface is not sufficient to do so.As the physical product was not returned, further analysis could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient presented to the clinic with increased instability in the left knee.The polyethylene liner was severely worn in the posterior aspects on the medial and lateral sides, and some plastic had broken off laterally.The small pieces of fractured plastic were removed from the joint.The trial implant was removed and the definitive implant placed.No intraoperative complications were reported.Review of the device history record 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: PERSONA ARTICULAR SURFACE FIXED BEARING (PS) LEFT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23747563
• Report Number: 3007963827-2025-00500
• Device Sequence Number: 6023649
• Product Code: MBH
• UDI-Device Identifier: 00889024237322
• UDI-Public: (01)00889024237322(17)260608(10)65048264
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/20/2026

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: 06/08/2026
• Device Catalogue Number: 42512400810
• Device Lot Number: 65048264
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male