BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL CUP IMPACTOR W/PLASTIC

    MDR report key: 2894326 · Received November 16, 2012

    Report

    Report Number
    2249697-2012-02394
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE THA, THE FINAL CUP IMPACT W/PLASTIC BROKE ON THE SURGICAL TABLE FOR DEVICES AFTER THE SURGEON NORMALLY USED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINAL CUP IMPACTOR W/PLASTIC INSTRUMENT HWA STRYKER ORTHOPAEDICS MAHWAH NA BPW13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other