BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM. CUP W/HA

    MDR report key: 1850347 · Received September 20, 2010

    Report

    Report Number
    9616680-2010-00585
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K072020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON PUT THE IMPLANT IN THE ACETABULUM AND TRIED TO MANIPULATE IT IN, BUT THE INSERTER KEPT SLIPPING OFF. HE TRIED TO ROTATE IT INTO POSITION, TRIED TO SEAT IT, AND COULD NOT. REMOVED THE ADM CUP AND IMPLANTED A TRIDENT PSL SHELL INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM. CUP W/HA IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G2948921

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other