BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM TRIAL CUP

    MDR report key: 1937709 · Received December 16, 2010

    Report

    Report Number
    9616680-2010-00832
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON REAMED TO A 54, PUT IN A 54 RIGHT ADM TRIAL; HE COULD NOT GET THE TRIAL OUT. SURGEON BACK SLAPS THE IMPACTOR AND THE IMPACTOR DISENGAGED FROM THE TRIAL. THEN HE TRIED TO MANEUVER THE TRIAL LEFT AND RIGHT AND THE POST ON THE ADM TRIAL BROKE OFF IN THE INSERTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION ADM TRIAL CUP INSTRUMENT LXH STRYKER ORTHOPAEDICS CORK NA G2986982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other