BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN ROTATING HINGED KNEE TIBIAL BEARING 12MM

    MDR report key: 12577620 · Received October 5, 2021

    Report

    Report Number
    0001825034-2021-02812
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K945028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF PHOTOGRAPHS PROVIDED IDENTIFIED THAT THE YOKE HAD FRACTURED AND SHOWED SIGNS OF BEING IMPLANTED. THE TIBIAL BEARING APPEARED WORN AND DISCOLORED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED 1997. CONCOMITANT DEVICES -KNE-FINN-BEARINGS- UNK CATALOG # N/I LOT #: 092610, FINN YOKE STD REINFORCED CATALOG #: 153865 LOT #: 377520. 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 MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034 - 2021 - 02813; 0001825034 - 2021 - 02812, INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED APPROXIMATELY 24 YEARS POST OPERATIVELY DUE TO IMPLANT WEAR AND FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474783 FINN ROTATING HINGED KNEE TIBIAL BEARING 12MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 092610

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R SEE H10 NARRATIVE.