BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG)

    MDR report key: 1132049 · Received August 21, 2008

    Report

    Report Number
    9616680-2008-00248
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE , THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 9616680-2008-00247.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT'S HIP WAS REVISED IN 2008. SURGEON STATED THAT THE STEM AND CUP WERE LOOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE (127 DEG) IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention