BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT DUAL - OFFSET HANDLE

    MDR report key: 3884889 · Received June 19, 2014

    Report

    Report Number
    0002249697-2014-02371
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K123604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF-AXIS FORCE TRANSMISSION INVOLVING A RIGHT DUAL - OFFSET HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE REPORTED EVENT COMES FROM A POST MARKET SURVEILLANCE SURVEY IN WHICH THE SURGEON STATES THAT HE BELIEVES THAT THE DUAL OFFSET LEADS TO OFF-AXIS FORCE TRANSMISSION RESULTING IN A WALLOWED OUT BROACH ENVELOPE. THESE COMMENTS ARE THE OPINION OF SURGEON AND DO NOT INDICATE AN ISSUE WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN DA CUP INSERTION HANDLE.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    REVIEW OF THE POST MARKET SURVEILLANCE SURVEYS NOTED THAT "THE ONLY PROBLEM WE FOUND WITH THE CUP INSERTION HANDLE WAS THE INABILITY TO ROTATE THE CUP INSIDE THE ACETABULUM WITHOUT IT LOOSENING FROM THE HANDLE."

    Description of Event or Problem · 1

    ADDITIONALLY REPORTED ON THE POST MARKET SURVEILLANCE SURVEY WAS "WAS PLEASED WITH THE LOCKING MECHANISM OF THE BROACH HANDLE BUT NOT THE DUAL OFFSET. HE BELIEVES THAT THE DUAL OFFSET LEADS TO OFF-AXIS FORCE TRANSMISSION RESULTING IN A 'WALLOWED' OUT BROACH ENVELOPE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360290 RIGHT DUAL - OFFSET HANDLE INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other