BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM BALL IMPACTOR TIP

    MDR report key: 3181292 · Received June 21, 2013

    Report

    Report Number
    0002249697-2013-02004
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. PROTOCOLS IN THE PROCESS OF BEING REVIEWED PER INTERNAL CORRECTIVE ACTION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY INVESTIGATED AND CAPA IS CURRENTLY OPEN TO INVESTIGATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A RIGHT TOTAL PRIMARY HIP AND ADM CUP. THE CUP INSERTER SLIPPED OFF AND DISENGAGED. THE SURGEON THEN TRIED TO REORIENT THE SHELL WITH THE IMPACTOR AND THE PLASTIC HEAD BROKE. USED ANOTHER AND IT BROKE. PLASTIC PIECES TAKEN OUT OF JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A RIGHT TOTAL PRIMARY HIP AND ADM CUP. THE CUP INSERTER SLIPPED OFF AND DISENGAGED. THE SURGEON THEN TRIED TO REORIENT THE SHELL WITH THE IMPACTOR AND THE PLASTIC HEAD BROKE. USED ANOTHER AND IT BROKE. PLASTIC PIECES TAKEN OUT OF JOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A RIGHT TOTAL PRIMARY HIP AND ADM CUP. THE CUP INSERTER SLIPPED OFF AND DISENGAGED. THE SURGEON THEN TRIED TO REORIENT THE SHELL WITH THE IMPACTOR AND THE PLASTIC HEAD BROKE. USED ANOTHER AND IT BROKE. PLASTIC PIECES TAKEN OUT OF JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282892 ADM BALL IMPACTOR TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other