BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - FEMORAL HEAD

    MDR report key: 1915648 · Received December 1, 2010

    Report

    Report Number
    9616680-2010-00789
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    September 9, 2008
    Report Date
    October 8, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR# 9616680-2010-00788.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT UNDERWENT REVISION ACETABULAR LINER, REVISION FEMORAL HEAD OF THE LEFT HIP DUE TO PAINFUL SQUEAKY TOTAL HIP REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - FEMORAL HEAD IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention