MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA 0° SPIKED KEEL RIGHT SIZE H OSSEOTI TIBIA; PROSTHESIS, KNEE

Catalog Number	42535008302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right knee surgery.Subsequently, the patient suffered from several knee effusions and pain and was revised approximately 1 year post-op.The rep noted that the femur had a lack of bony ingrowth.The patella was retained.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42508607002 - cruciate retaining right size 11 pps standard femur - 66604316.42522100910 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes g-h/cr femur sizes 8-11 - 66689627.42540000038 - all poly patella cemented 38 mm diameter - 66651077.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 the event is confirmed.Visual examination of the returned product identified signs of being implanted (nicked/gouged/worn and surface scratches.Foreign material is covering almost the full plate with spiked surface.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Operative notes and imaging were provided and reviewed by a healthcare professional.Review of the imaging revealed a right total knee arthroplasty without radiographic hardware complication.Of note, the quality/resolution of the image is suboptimal with substantial image blurring noted, which could limit detection of subtle findings such as radiolucency around the implant.The provided ct report indicates no loosening but does identify synovitis.A definitive root cause cannot 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 available at the time of this report.

• Brand Name: PERSONA 0° SPIKED KEEL RIGHT SIZE H OSSEOTI TIBIA
• 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: 23817031
• Report Number: 3007963827-2025-00514
• Device Sequence Number: 9963681
• Product Code: JWH
• UDI-Device Identifier: 00889024631991
• UDI-Public: (01)00889024631991(17)340503(10)66460988
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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 Catalogue Number: 42535008302
• Device Lot Number: 66460988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 112 KG