MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEM CR POR CCR NRW SZ 8 L; PROSTHESIS, KNEE

Catalog Number	42502206401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42540200032 - all poly pat ve 32 mm dia - 65061520.42532007101 - psn tib stm 5 deg sz e l - 65361036.42512100810 - psn mc ve asf l 10mm 8-11/ef - 65362700.66022663 - palacos r + g (1x40) - 60771089.G2: australia.H6: mechanical (g04) - femur.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.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Approximately 3.5 years post-op, the patient was experiencing pain without relief from physiotherapy, a pain management specialist, and rehabilitation.Imaging revealed increased uptake at the patella and medial tibial area.Subsequently, the patient was revised.All components were revised.There was no loosening seen, however, the surgeon noted areas of softer bone.Attempts have been made and all available information has been provided.
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; d2; g1; g3; g6; h1; h2; h3; h4; h6; h10.The event cannot be confirmed.Visual examination of the provided pictures showed the explanted implants; visual and dimensional evaluations could not be performed.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.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: radiolucency underlying the medial tibial plate is suspicious for osteolysis and a low lying patella.These findings may be associated with pain and increased activity on bone scan.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusion or information, a supplemental report will be filed accordingly, zimmer biomer will continue to monitor for trends.

• Brand Name: PERSONA FEM CR POR CCR NRW SZ 8 L
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24052775
• Report Number: 0001822565-2026-00151
• Device Sequence Number: 15916654
• Product Code: MBH
• UDI-Device Identifier: 00889024470095
• UDI-Public: (01)00889024470095(17)320417(10)65313223
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/23/2026

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: 42502206401
• Device Lot Number: 65313223
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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: Unknown