MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED SIZE 6 RIGHT MEDIAL; PROSTHESIS, KNEE

Catalog Number	42558000602
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Arthritis (1723); Cyst(s) (1800); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42528200809 - partial articular surface - 66059831.42538000802 - partial tibial cemented - 65833477.Unknown cement.G2: foreign - event occurred in australia.H6: component code: mechanical (g04) - femur.The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient underwent a knee revision 2 years post implantation due to natural knee arthritic condition progression and femoral cysts.It was reported that no further information is available.
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; h4; h6; h11.The reported event was confirmed by review of x-rays.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: radiolucency around the femoral component on the ap view with tilt of the femoral component likely representing loosening/subsidence.There is medial compartment joint space narrowing and apparent varus alignment at the knee.A small knee effusion is present.The bone mineral density is decreased and there are subchondral cystic changes in the lateral femoral condyle and patellofemoral compartment osteophytes.Impression: cemented unicompartmental arthroplasty with periprosthetic lucency and malposition of the femoral component concerning for osteolysis and aseptic loosening/subsidence.There is also medial compartment joint space narrowing concerning for polyethylene wear/malposition and apparent varus alignment at the knee 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 PARTIAL FEMUR CEMENTED SIZE 6 RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23057580
• Report Number: 0001825034-2025-02907
• Device Sequence Number: 18288163
• Product Code: HSX
• UDI-Device Identifier: 00880304808577
• UDI-Public: (01)00880304808577(17)330710(10)65875855
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/25/2025

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: 42558000602
• Device Lot Number: 65875855
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male
• Patient Weight: 113 KG