BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TIB STM

    MDR report key: 21079453 · Received January 6, 2025

    Report

    Report Number
    3007963827-2025-00013
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    December 10, 2024
    Report Date
    May 1, 2025
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024471061
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: PERSONA MC VE ASF R CATALOG # 42522100812 LOT # 64649805. ALL POLY PATELLA CEMENTED 35 MM DIAMETER CATALOG # 42540000035 LOT # 64775275. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8 CATALOG # 42502606402 LOT # 64638054. PERSONA CEM FEM/CEM TIB/M CATALOG # 98-0002-400-22 LOT # UNK. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H6, H10.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H9, H10 LOOSENING NOT CONFIRMED ON TIBIA. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO UNKNOWN REASON. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FOUR YEARS POST IMPLANTATION DUE TO LOOSE TIBIAL COMPONENT. GROSS TIBIA FAILURE AND PITTING WAS NOTICED ON THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357024 PERSONA TIB STM PROSTHESIS KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64624454 00889024471061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H10 NARRATIVE.