BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX M-HA HIP STEM

    MDR report key: 5784929 · Received July 12, 2016

    Report

    Report Number
    0002249697-2016-02215
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 13, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K920193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A OMNIFLEX STEM 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: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. 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 X-RAYS, 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    RIGHT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE. PUT IN A RESTORATION MOD.

    Description of Event or Problem · 1

    RIGHT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE. PUT IN A RESTORATION MOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438302 OMNIFLEX M-HA HIP STEM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL STRYKER ORTHOPAEDICS-MAHWAH JC53AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention