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

Catalog Number	42512600410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented standard left size 5: catalog#42504605801, lot#ni; tibia fixed cemented left size c: catalog#42542006401, lot#ni; femoral distal augment size 5, 5+ 5 mm thickness: catalog#42557205805, lot#ni; stem extension tapered cemented 14 mm diameter +75 mm length: catalog#42560007514, lot#ni; tibial augment half block left medial size cd 10 mm thickness: catalog#42556203310, lot#ni; stem extension straight splined uncemented 11 mm diameter +135 mm length: catalog#42560113511, lot#ni.G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.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 total knee arthroplasty.Approximately seven (7) months post-implantation, the patient began to experience instability and underwent revision surgery to exchange the polyethylene bearing.Due diligence is complete as multiple attempts have been made; it was reported that no additional information is available.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h4; h6; h11.Visual examination of the returned product identified signs of use.Gouges visible on the articulating surface, distal surface, and post.Flaring visible on the dovetail feature.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a healthcare professional.They state that the initial post-operative radiograph following the total knee arthroplasty showed normal anatomic alignment without abnormality.However, a follow-up radiograph prior to the revision showed new varus malalignment of the left knee with narrowing of the femorotibial space.The reviewing radiologist suspected abnormality of the articular surface liner, either displacement or very early wear, as the likely contributor to the varus alignment that led to revision.Root cause was unable to be determined.Reported event was unable to be confirmed.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 CPS 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: 21412630
• Report Number: 3007963827-2025-00063
• Device Sequence Number: 8524015
• Product Code: MBH
• UDI-Device Identifier: 00889024237858
• UDI-Public: (01)00889024237858(17)281211(10)66177699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/29/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42512600410
• Device Lot Number: 66177699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown