BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODC HIP STEM

    MDR report key: 3984388 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03040
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K913812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A ODC HIP STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: INDICATED THAT THERE WAS ONE NC RELATED TO MISSING IFU INFORMATION ON THE ROUTER. OTHERWISE, THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE REPORTED EVENT INVOLVES REVISION DUE TO RIGHT HIP LOOSENING. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. IN ORDER TO COMPLETE A FULL INVESTIGATION, ITEMS SUCH AS OPERATIVE NOTES, X-RAYS, AND PATIENT HISTORY ARE NEEDED TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED ON A RIGHT HIP DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460717 ODC HIP STEM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MERJYW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention