BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 563114 · Received November 19, 2004

    Report

    Report Number
    MW1033831
    Event Type
    Other
    Date Received
    November 19, 2004
    Date of Event
    November 18, 2004
    Report Date
    November 19, 2004
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL HIP ARTHROPLASTY, THE ACETABULAR INSERTER, DEVICE USED TO PUT THE PELVIC PORTION OF THE PROSTHESIS IN PLACE, WOULD NOT SEPARATE FROM THE PROSTHESIS. THE HIP PART OF THE PROSTHESIS HAD TO BE REMOVED FROM THE PT WITHOUT INSERTION. AFTER WHICH THE SURGEON WAS ABLE TO REMOVE THE INSERTER AND OBTAIN A NEW ONE. THE HIP PORTION OF THE PROSTHESIS WAS PROPERLY PLACED, POST OP EVAL OF THE FAILED DEVICE REVEALED A MISSING/BROKEN PIN. X-RAYS REVEALED THAT THIS PIN IS STILL IN THE PT BUT IS IN A PART OF THE SOFT TISSUE THAT WOULD MAKE IT HARD TO FIND. SINCE THE PIN WAS STERILE, IS NOT IN A SPOT THAT WOULD IMPACT FUNCTION OF THE HIP AND WOULD BE ALMOST IMPOSSIBLE TO FIND IN THE SOFT TISSUE THE PIN WAS LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MIH CURVED ACETABULAR IMPACTOR HANDLE LXH BIOMET ORTHOPEDICS * 709110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other