BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL CLUSTER SHELL LEFT

    MDR report key: 2010637 · Received February 24, 2011

    Report

    Report Number
    9616680-2011-00084
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PATIENT HAD A REVISION AND HE IS HAVING LOTS OF PROBLEMS WITH IT. HE CLAIMS IT WAS A BAD HIP. HE WOULD LIKE TO BE COMPENSATED FOR HIS REVISION. HE HAS A LOT OF PAIN. HE WAS OUT OF WORK FOR 3 MONTHS. HIS LIFE HASN'T BEEN THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL CLUSTER SHELL LEFT IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention