MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 11 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet.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 patient had a fall at home and was revised for unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 the patient fell and ruptured his extensor mechanism in the right knee after total knee replacement.While the extensor repair was being conducted the surgeon chose to exchange the bearing and go with the additional stability of the cps bearing.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h4, h6, h11 visual examination of the returned product identified signs of use in the form of pitting and gouges on the surfaces.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.Complaint is not confirmed.As it is unknown why or how the patient fell in their home, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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) RIGHT 11 MM
• 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: 21152380
• Report Number: 3007963827-2025-00018
• Device Sequence Number: 8996813
• Product Code: JWH
• UDI-Device Identifier: 00889024643284
• UDI-Public: (01)00889024643284(17)280217(10)66229384
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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 Model Number: N/A
• Device Catalogue Number: 42521400711
• Device Lot Number: 66229384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2024
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/12/2025; 04/30/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/06/2025; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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: Male