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

Catalog Number	42511400710
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in united kingdom.D10: concomitant medical products unknown persona femoral component 42532007501 - tibial component - 65941709.The device will not be returned for analysis, as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a patient had an initial total knee arthroplasty.Subsequently, the patient began experiencing pain, ongoing swelling, joint effusions, persistent clicking, and giving away.Radiographic imaging, serum infection markers, and an aspiration were performed 8 months post implantation and the testing rendered no significant findings.Joint laxity medially and laterally found upon assessment.
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: b4; b5; g3; g6; h1; h2; h3; h6; h10; h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided and reviewed state that the patient with a history of obesity, osteoarthritis, and osgood schlatter¿s disease, underwent a cemented left total knee arthroplasty without patella replacement.Postoperatively, the patient developed persistent symptoms including mild pain reported 3 months post op, swelling, recurrent effusions, clicking, episodes of the knee giving way and instability.Imaging from 7 months post op showed satisfactory alignment without lucency or loosening.Clinical assessment identified a large effusion and approximately 2 mm of medial and lateral laxity.A revision procedure, either polyethylene exchange or full revision, was planned within four months.Gp clinical letters provided confirm the reported event.A definitive root cause cannot be determined.The complaint is 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.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections have been updated: b3; b4; b5; d6b; g3; h2; h5; h6; h11.Additional information has prompted a review of the previously reported investigation results.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient had an initial total knee arthroplasty.Subsequently, the patient began experiencing pain, ongoing swelling, joint effusions, persistent clicking, and giving away.Radiographic imaging, serum infection markers, and an aspiration were performed 8 months post implantation, and the testing rendered no significant findings.Joint laxity medially and laterally found upon assessment.Subsequently, one year post-implantation, the patient underwent a revision procedure.The articular surface was exchanged for a larger size without complication and the patient's stability issues during range of motion have been reported as resolved.The femoral and tibial components remain implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records provided and reviewed state that the patient with a history of obesity, osteoarthritis, and osgood schlatter's disease underwent a cemented left total knee arthroplasty without patella replacement.Postoperatively, the patient developed persistent symptoms including mild pain reported at the 3-month post-operative follow-up, ongoing swelling, a persistent effusion, clicking, and episodes of the knee giving way and instability.Imaging later showed satisfactory alignment without lucency or loosening.Clinical assessment identified a large effusion and approximately 2 mm of medial and lateral laxity.The patient subsequently underwent a revision procedure, during which the poly bearing surface was exchanged for a larger size.Recovery was uneventful and the patient was discharged the same day.This resolved the patient's stability issues during range of motion.Reported event was confirmed by review of provided medical records.Root cause was unable to be determined.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.
Event or Problem Description
No further event information at time of this report.

• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22669006
• Report Number: 3007963827-2025-00300
• Device Sequence Number: 3702039
• Product Code: JWH
• UDI-Device Identifier: 00889024641341
• UDI-Public: (01)00889024641341(17)280509(10)65778821
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2026

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: Lay User/Patient
• Device Catalogue Number: 42511400710
• Device Lot Number: 65778821
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 12/26/2025; 03/11/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/25/2025; 01/22/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 110 KG