BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #5

    MDR report key: 4221741 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04143
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED MEDICAL DEVICE BASED ON ADDITIONAL INFORMATION. THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING STEM LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT CONFIRMED THE EVENT BUT COULD NOT DETERMINE A ROOT CAUSE. A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED: RADIOLOGY SHOWS AN ADEQUATE SIZE AND POSITION OF THE ORIGINAL COMPONENTS BUT THE X-RAY AT 8-MONTHS SHOWS RADIOLUCENT LINES AND BONE RESORPTION ALL AROUND THE PROXIMAL STEM SECTION PLUS CORTICAL HYPERTROPHY AND PEDESTAL FORMATION AROUND THE STEM TIP ALL INDICATIVE FOR STEM LOOSENING AS CONFIRMED DURING REVISION SURGERY. NO EXPLANTS WERE RETURNED FOR INVESTIGATION. THE FAILURE OF THIS CASE HAS MOST PROBABLY BEEN CAUSED BY AN ADVERSE MIX OF PATIENT-RELATED AND PROCEDURE-RELATED FACTORS REGARDING COMPONENT CHOICE IN A FEMUR WITH SOMEWHAT ABNORMAL GEOMETRY AND AGE-RELATED EFFECTS. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCH ASSOCIATE, REPORTED THAT A REVISION OPERATION OF A FEMORAL COMPONENT WAS REQUIRED BECAUSE OF ALLEGED LOOSENING OF THE COMPONENT.

    Description of Event or Problem · 1

    UPDATE - THE PATIENT HAD A FAST AND FULLY LOADED MOBILIZATION AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703288 ACCOLADE PLUS TMZF HIP STEM #5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 39189602

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention