MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE E; PROSTHESIS, KNEE

Catalog Number	42530007102
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee revision approximately 11 months post implantation due to the tibia implant subsiding.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: 42522000510 - articular surface fixed bearing (cr) right 10 mm height -(b)(4).G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
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; h6; h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.X rays were provided and reviewed by mmi, the resulting radiology report states the following: imaging findings changes of knee arthroplasty without patellar resurfacing and non-cemented components.Geographic radiolucency deep to the medial tibial tray suspicious for osteolysis and subsidence of the tibial component into varus alignment.Thin lucency at the bone-prosthesis interface of the femoral component is of questionable significance.There is incomplete coverage of the medial lateral and posterior tibial plateau by the tibial component.Small to moderate knee effusion.Impression right knee arthroplasty with radiolucency around the tibial component suspicious for osteolysis and subsidence of the tibial component.There is incomplete coverage of the medial lateral and posterior tibial plateau by the tibial component and possible decreased bone density, which have been described as risk factors for migration in cementless tibial components.A definitive root cause cannot be determined.The complaint is confirmed.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 TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE E
• 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: 23057564
• Report Number: 0001822565-2025-03409
• Device Sequence Number: 8581822
• Product Code: MBH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562(17)330617(10)66023117
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 42530007102
• Device Lot Number: 66023117
• 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: 08/23/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male