BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRIDENT HIP REPLACEMENT

    MDR report key: 2140733 · Received May 31, 2011

    Report

    Report Number
    9616680-2011-00348
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    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, "THE PATIENT WROTE A LETTER EXPRESSING CONCERN REGARDING HIS TRIDENT HIP REPLACEMENT. APPROXIMATELY 1 YEAR AFTER IMPLANT SURGERY, THE PATIENT EXPERIENCED 'SQUEAKING' OF HIS HIP REPLACEMENT WHICH CONTINUES TO PRESENT DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIDENT HIP REPLACEMENT IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other