BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 1060514 · Received June 11, 2008

    Report

    Report Number
    9616680-2008-00145
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REAMED TO 51, TRIALED, IMPLANTED 52 PSL CUP. WHEN TRYING TO SEAT 0 DEGREE E INSERT, INSERT WOULD NOT FULLY SEAT. SURGEON NOTICED A SLIGHTLY ROCKING AND CLICKING SOUND OF INSERT. CHECKED TO MAKE SURE NO TISSUE IMPINGEMENT AS ISSUE. REMOVED INSERT, CHECKED TO SEE IF TISSUE IN THE CUP, NONE NOTICED. CHECKED TO MAKE SURE SCREWS WERE FULLY SEATED AND THEY WERE. TRIED TO SEAT 10 DEGREES INSERT WITH SAME ISSUES. REMOVED INSERT AGAIN, REMOVED CUP, REAMED UP TO 54 AND SEATING PSL 54 CUP. SEATED CORRESPONDING 0 DEGREE 36F INSERT WITH NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 1V6MHE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other