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

Catalog Number	42535006702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial bilateral knee surgery.Approximately 7 weeks post-op, the patient was revised due to an anteromedial fracture of the right proximal tibia.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: 42502206402 - femur trabecular metal cruciate retaining (cr) narrow porous - 66883659 42522100510 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes c-d/cr femur sizes 8-9 - 67110013.G2 : foreign country : australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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.The event is confirmed.Visual examination of the provided picture identified the explanted tibial plate with foreign debris on the surface.As the device was not returned, further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap and lateral views of the right knee show changes of knee arthroplasty without patellar resurfacing.Radiolucency around the tibial component consistent with loosening and anterior subsidence of the tibial component.There is an additional mildly impacted fracture of the medial tibial metaphysis.Moderate knee joint effusion.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 0A SPIKED KEEL RIGHT SIZE D 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: 23486261
• Report Number: 3007963827-2025-00442
• Device Sequence Number: 13383892
• Product Code: JWH
• UDI-Device Identifier: 00889024631915
• UDI-Public: (01)00889024631915(17)341113(10)67018569
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 42535006702
• Device Lot Number: 67018569
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female