BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APHIS PLATEAU RADIAL T1

    MDR report key: 6580142 · Received May 19, 2017

    Report

    Report Number
    3006946279-2017-00095
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    March 1, 2017
    Report Date
    May 19, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JWJ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT: (B)(6) OF 2017. IMPLANT DATE: UNKNOWN DATE, 2002. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042032. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND NO PRODUCT WAS RETURNED. DHR COULD NOT BE REVIEWED DUE TO THE LACK OF INFORMATION RECEIVED. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A WRIST REVISION DUE TO WEAR OF THE POLYETHYLENE LINER APPROXIMATELY FIFTEEN YEARS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360560 APHIS PLATEAU RADIAL T1 PROSTHESIS, WRIST JWJ BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention