BEUDAMED
    FDA Adverse Event Other Summary report: N

    M2A-38 CUP INSERTER/EXTRACTOR

    MDR report key: 508067 · Received January 2, 2004

    Report

    Report Number
    1825034-2003-00149
    Event Type
    Other
    Date Received
    January 2, 2004
    Date of Event
    December 3, 2003
    Report Date
    December 8, 2003
    Manufacturer
    BIOMET, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING TOTAL HIP ARTHROPLASTY IN 2003, POST-OPERATIVE RADIOGRAPHS DETECTED PRESENCE OF FOREIGN BODY DETERMINED TO BE FRAGMENT FROM INSERTION INSTRUMENT. 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 348490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other