MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIB POR 0 DEG SPK KEL G LT; PROSTHESIS, KNEE

Catalog Number	42535007901
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42512100910, articular surface medial congruent (mc) left 10 mm height use with tibia sizes g-h/cr femur sizes 8-11, lot # 66682319.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.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 approximately 3 months post implantation of an initial left total knee arthroplasty, the patient was revised due to tibial subsidence, and tipping into varus.Only the tibial component was revised.No additional information on the event is available.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6.The reported event was confirmed by review of x-rays.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: imaging findings: femoral and tibial knee arthroplasty components are present.The tibial component is undersized with slight medial overhang.Linear radiolucency underlying the medial tibial baseplate may be due to medial tibial plateau cut being deeper than lateral tibial plateau cut (versus due to loosening).There is mild varus tilt of the tibial component associated with an small wedge-shaped radiolucency at the lateral tibial plate-bone interface and along the tibial stem medial metal-bone interface, consistent with loosening.Impression - ap image of the left knee shows femoral and tibial knee arthroplasty components.Tibial component is undersized with slight medial overhang, and is loose.Linear radiolucency underlying the medial tibial baseplate may be due to medial tibial plateau cut being deeper than lateral tibial plateau cut (versus radiolucency due to loosening).This finding is associated with varus tilt of the tibial component and radiolucencies at the lateral tibial plate-bone interface and at the tibial stem medial metal-bone interface.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: PERSONA TIB POR 0 DEG SPK KEL G LT
• 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: 23316238
• Report Number: 3007963827-2025-00413
• Device Sequence Number: 4967740
• Product Code: JWH
• UDI-Device Identifier: 00889024631960
• UDI-Public: (01)00889024631960(17)350309(10)67197877
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 42535007901
• Device Lot Number: 67197877
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: Male