MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 13 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42521400513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.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 an initial right total knee arthroplasty.Subsequently, approximately nine (9) years post-implantation, the patient underwent a revision surgery due to instability.The articular surface was replaced without reported complication.
Event or Problem Description
Upon receipt of additional information, the previously reported event was found to be a duplicate complaint entry.The event has been reported under 0002648920-2025-00229.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; h2; h10; h11.Upon receipt of additional information, the previously reported event was found to be a duplicate complaint entry.The event has been reported under 0002648920-2025-00229.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: PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 13 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22921045
• Report Number: 0002648920-2025-00227
• Device Sequence Number: 18427911
• Product Code: JWH
• UDI-Device Identifier: 00889024240810
• UDI-Public: (01)00889024240810(17)240430(10)63346587
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 42521400513
• Device Lot Number: 63346587
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2016
• 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 Sex: Female
• Patient Weight: 83 KG