BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 1884573 · Received October 21, 2010

    Report

    Report Number
    9616680-2010-00667
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PHYSICIAN WAS POSITIONING THE ADM CUP IN THE ACETABULUM WHEN THE CUP CAME OFF THE POSITIONER. THE PHYSICIAN TRIED TO UNSCREW THE POSITIONER SO HE COULD PUT IT BACK IN THE CUP. POSITIONER WAS FROZEN AND WOULD NOT UNSCREW. THE PHYSICIAN TOOK THE SECONDARY IMPACTOR AND SAT THE CUP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM MANCHON EXPANS INSTRUMENT JDI STRYKER ORTHOPAEDICS CORK NA G2960894

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other