BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT TOTAL HIP REPLACEMENT/ACCOLADE TMZF

    MDR report key: 1871238 · Received October 13, 2010

    Report

    Report Number
    9616680-2010-00633
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    March 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 HAS BEEN EXPERIENCING EXTREME PAIN AND UPON STANDING, IT TURNS INTO A SHOOTING PAIN. PATIENT SPOKE TO HIS SURGEON AND HAS NOT RECEIVED MUCH INFORMATION. PATIENT WOULD LIKE TO KNOW WHY HE IS EXPERIENCING THIS PAIN AND HAS AGREED FOR STRYKER TO CONTACT HIS SURGEON. PATIENT WAS ALSO ASKED TO OBTAIN COPIES OF HIS MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT TOTAL HIP REPLACEMENT/ACCOLADE TMZF IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other