BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALL POLY CUP-CROSSFIRE

    MDR report key: 1243831 · Received November 24, 2008

    Report

    Report Number
    2249697-2008-00372
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K001956
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. IT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, " IN 2008, DOCTOR WAS PERFORMING A REVISION TOTAL HIP ARTHROPLASTY AT MEDICAL CENTER. HE SELECTED A 52MM TRIDENT ALL POLY TO CEMENT INTO A GAP CUP. UPON OPENING THE IMPLANT, DOCTOR STATED, "THIS PLASTIC LOOKS YELLOW." HE WAS VERY CONCERNED AND REFUSED TO IMPLANT THE CUP. I HAD A BACKUP IMPLANT AND OPENED IT AND HE PUT THEM SIDE BY SIDE AND THE FIRST CUP WAS CLEARLY A SHADE OF YELLOW AS COMPARED WITH THE SECOND. DOCTOR EXPRESSED CONCERNED ABOUT POSSIBLE OXIDATION OF THE POLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ALL POLY CUP-CROSSFIRE IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 2ZA0ZA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention