BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARPE HEAD CURVE LONG +2

    MDR report key: 8266227 · Received January 22, 2019

    Report

    Report Number
    3006946279-2019-00059
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    July 24, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWG
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE IT COULD NOT BE ANALYZED THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO ROOT CAUSE COULD BE DETERMINED, HOWEVER THIS IS AN EXPECTED RISK THAT THE IMPLANT CAN BE DAMAGED IN CASE OF FALL OF THE PATIENT 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 PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION AFTER A FALL. THE IMPLANT HEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60929 ARPE HEAD CURVE LONG +2 METACARPAL PROSTHESIS KWG BIOMET FRANCE S.A.R.L. N/A 0001267935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R