MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0° KEEL RIGHT SIZE C CEMENTED TIBIA; PROSTHESIS, KNEE

Catalog Number	42536006402
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 4-5: catalog#: 42522100311, lot#: 65769258; femur trabecular metal cruciate retaining (cr) narrow porous: catalog#: 42502205802, lot#: 66339207; optipac 60 biomet bc r: catalog#: 110035375, lot#: av12aa0511.G2: foreign: japan.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately three (3) months post-implantation, the patient began to experience pain and instability.Diagnostic images confirmed that the tibial component had sunk by three (3) millimeters.Medical intervention has not been performed however a potential revision surgery is being discussed with the patient and surgeon.Due diligence is in progress for this event; to date no additional information has been provided.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately three (3) months post-implantation, the patient began to experience pain and instability.Diagnostic images confirmed that the tibial component had sunk by three (3) millimeters.A revision surgery was performed to replace the affected tibial tray without complication.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b3; b4; b5; d6b; g3; h2; h6; h11.The investigation is in progress.Upon completion of the investigation, 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; h4; h6.The event cannot be confirmed.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.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 healthcare professional.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 0° KEEL RIGHT SIZE C CEMENTED TIBIA
• 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: 22106058
• Report Number: 0001822565-2025-01580
• Device Sequence Number: 15254354
• Product Code: JWH
• UDI-Device Identifier: 00889024632073
• UDI-Public: (01)00889024632073(17)340101(10)66461401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2025

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: 42536006402
• Device Lot Number: 66461401
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 09/15/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/25/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female