BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEM COMP STD

    MDR report key: 3870268 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02206
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION FOR AN UNSPECIFIED REASON INVOLVING A GMRS PROXIMAL FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO X-RAYS OR MEDICAL INFORMATION RELEVANT TO THIS REVISION PROCEDURE WERE PROVIDED. DEVICE HISTORY REVIEW: DHR REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. THE REPORTED REVISION SURGERY IS NOT CONFIRMED AND THE REASON FOR THE REVISION SURGERY IS UNKNOWN. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT 6495-6-040 GMRS EXTENSION PIECE 40MM LOT CODE SY34X.UNKNOWN V40 BIOLOX HEAD, UNKNOWN LOT CODE.THE INFORMATION RECEIVED DOES NOT INDICATE WHICH IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE THAT LED TO THE REVISION SURGERY. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A HIP, SALES REP UNAWARE OF THE MEDICAL REASON FOR THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF A HIP, SALES REP UNAWARE OF THE MEDICAL REASON FOR THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347394 PROXIMAL FEM COMP STD IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH STF8C

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention