BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3945415 · Received July 21, 2014

    Report

    Report Number
    0002249697-2014-02803
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN LINER. THE V40 COCR LFIT HEAD 40MM/+8; CAT# 6260-9-340; LOT# 56HMRD WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING AN UNKNOWN LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. -DEVICE HISTORY REVIEW: NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. -COMPLAINT HISTORY REVIEW: NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PRE- AND POST-OP XRAYS, PATIENT HISTORY, HISTOPATHOLOGY REPORT & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    HIP REVISION DUE TO PAIN. LINER EXCHANGE AND HEAD EXCHANGE. ORIGINAL IMPLANT WAS A V40 40MM +8 HEAD ON A 127 DEGREE ACCOLADE TMZF SIZE 2.5. REPLACEMENT HEAD WAS A CERAMIC 36MM.

    Description of Event or Problem · 1

    HIP REVISION DUE TO PAIN. LINER EXCHANGE AND HEAD EXCHANGE. ORIGINAL IMPLANT WAS A V40 40MM +8 HEAD ON A 127DEGREE ACCOLADE TMZF SIZE 2.5. REPLACEMENT HEAD WAS A CERAMIC 36MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426274 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention