BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #6

    MDR report key: 3781257 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01625
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 542-11-60G, LOT # 1627002, DESCRIPTION: TRIDENT PSL WITH PUREFIX HA 60MM. CAT # 2030-6545-1, LOT # 74338602, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 45MM. CAT # 6260-7-232, LOT # 2962701, DESCRIPTION: 32MM +4MM V40 ALUMINA HEAD. CAT # 621-00-32G, LOT # 02697501, DESCRIPTION: TRIDENT 0° CROSSFIRE INSERT 32 MM ID. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PERIPSOTHETIC FRACTURE AND INFECTION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED 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. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND CREATED PERIPROSTHETIC FRACTURE OF RIGHT FEMUR. IT ALSO BECAME INFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND CREATED PERIPROSTHETIC FRACTURE OF RIGHT FEMUR. IT ALSO BECAME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259174 ACCOLADE TMZF HIP STEM #6 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 2072101

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R