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

Catalog Number	42512200510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately two years and three months post implantation due to instability.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).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.
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, d2, g1, g3, g6, h1, h2, h3, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.This complaint is not 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 (UC) 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 BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22169960
• Report Number: 3007963827-2025-00230
• Device Sequence Number: 13061343
• Product Code: MBH
• UDI-Device Identifier: 00889024236523
• UDI-Public: (01)00889024236523(17)271010(10)65542400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/07/2025

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: Health Professional
• Device Catalogue Number: 42512200510
• Device Lot Number: 65542400
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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 Sex: Female