BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM OSS RIGHT FLANGED PROX. FEMORAL

    MDR report key: 1016413 · Received March 14, 2008

    Report

    Report Number
    1825034-2008-00080
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    HSA
    PMA / PMN Number
    CUSTOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPONENT WAS PACKAGED WITH LONG SCREWS ONLY INSTEAD OF LONG AND SHORT SCREW COMPONENTS. DURING PROCEDURE, SURGEON CUT OFF SCREW COMPONENT WITH A MIDAS REX TO REACH DESIRED SCREW LENGTH, BUT COULD NOT THREAD THE SCREW COMPONENT IN THE THREADED HOLE. POST-OPERATIVE RADIOGRAPHS INDICATE THAT SCREW COMPONENT WAS INSERTED INTO A NON-THREADED HOLE IN THE PROXIMAL BODY. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM OSS RIGHT FLANGED PROX. FEMORAL HSA BIOMET, INC. NA 809540

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK