BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY/HEAD PF RASP/PROV.

    MDR report key: 377454 · Received February 14, 2002

    Report

    Report Number
    1825034-2002-00016
    Event Type
    Injury
    Date Received
    February 14, 2002
    Date of Event
    October 2, 2000
    Report Date
    February 13, 2002
    Manufacturer
    BIOMET, INC.
    Product Code
    GAC
    Removal / Correction Number
    NOT APPLICABLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY IN 2001, TRUNION OF INSTRUMENT FRACTURED. LATERAL EDGE OF FEMUR WAS NOTCHED TO FACILITATE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD PF RASP/PROV. RASP/PROVISIONAL GAC BIOMET, INC. NA 927570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R