BEUDAMED
    FDA Adverse Event Other Summary report: N

    M2A-38 CUP INSERTER/EXTRACTOR

    MDR report key: 542439 · Received August 26, 2004

    Report

    Report Number
    1825034-2004-00077
    Event Type
    Other
    Date Received
    August 26, 2004
    Date of Event
    April 27, 2004
    Report Date
    August 2, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACETABULAR INSERTER PLATE TAB BROKE OFF INTRA-OPERATIVELY DURING TOTAL HIP ARTHROPLASTY IN 2004. FRAGMENT WAS NOT DISCOVERED UNTIL EXAMINATION OF POST-OPERATIVE RADIOGRAPHS. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-38 CUP INSERTER/EXTRACTOR INSTRUM.INSERTER/EXTRACTOR LXH BIOMET, INC. NA 348480

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other