BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY RESTORATION ADM CURVED CUP HOLDER PER FILE H1702

    MDR report key: 2964599 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00703
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT AND THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SAME LOT NUMBER. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO ITEMS WERE RETURNED FOR REVIEW. THE REPORTED DEVICES WOULD BE REQUIRED TO CONFIRM THE REPORTED EVENT AND DETERMINE THE ROOT CAUSE. THE REPORTED EVENT REGARDING MATING ISSUES INVOLVING A SPECIALTY RESTORATION ADM CURVED CUP HOLDER AND THE CUP WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE OFFSET IMPACTOR HANDLE WOULD NOT COME OFF THE CUP AFTER ATTEMPTING TO IMPACT THE CUP INTO THE PATIENT. THE CUP WOULD NOT COME OFF THE IMPACTOR, SO WE OPENED A NEW CUP THE SAME SIZE. WE USED THE STRAIGHT ADM CUP IMPACTOR AND THE NEW CUP WAS IMPLANTED WITH NO PROBLEMS.

    Description of Event or Problem · 1

    THE OFFSET IMPACTOR HANDLE WOULD NOT COME OFF THE CUP AFTER ATTEMPTING TO IMPACT THE CUP INTO THE PATIENT. THE CUP WOULD NOT COME OFF THE IMPACTOR, SO WE OPENED A NEW CUP THE SAME SIZE. WE USED THE STRAIGHT ADM CUP IMPACTOR AND THE NEW CUP WAS IMPLANTED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69092 SPECIALTY RESTORATION ADM CURVED CUP HOLDER PER FILE H1702 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH GBT6H124A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other