BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #4

    MDR report key: 3051297 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01246
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    June 1, 2007
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. X-RAYS, CLINICAL HISTORY, AND OPERATIVE REPORTS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6565-0-132, LOT # 18112903, DESCRIPTION: ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK; CAT # 625-0T-32F, LOT # 15868102, DESCRIPTION: TRIDENT ALUMINA INSERT; CAT # 502-01-56F, LOT # 20112101, DESCRIPTION: TRIDENT HEMISPHERICAL CLUSTER 56MM; CAT # 2030-6525-1, LOT # 511MRA AND 85WMRA, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 25MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S REVISION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. X-RAYS, CLINICAL HISTORY, AND OPERATIVE REPORTS ARE NEEDED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE HIP HAS NEVER FELT RIGHT. IN (B)(6) 2007, THE PATIENT WENT TO SEE DOCTOR ABOUT ISSUES WITH THE HIP. PATIENT COMPLAINS OF ON AND OFF PAIN. ABOUT TWO TO THREE WEEKS AGO PATIENT COMPLAINED OF NOT BEING ABLE TO MOVE AT ALL. PATIENT ALSO HAS LESION ON LEFT HIP AND FACE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE HIP HAS NEVER FELT RIGHT. IN (B)(6) 2007, THE PATIENT WENT TO SEE DOCTOR ABOUT ISSUES WITH THE HIP. PATIENT COMPLAINS OF ON AND OFF PAIN. ABOUT TWO TO THREE WEEKS AGO PATIENT COMPLAINED OF NOT BEING ABLE TO MOVE AT ALL. PATIENT ALSO HAS LESION ON LEFT HIP AND FACE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE HIP HAS NEVER FELT RIGHT. IN (B)(6) 2007, THE PATIENT WENT TO SEE DOCTOR ABOUT ISSUES WITH THE HIP. PATIENT COMPLAINS OF ON AND OFF PAIN. ABOUT TWO TO THREE WEEKS AGO PATIENT COMPLAINED OF NOT BEING ABLE TO MOVE AT ALL. PATIENT ALSO HAS LESION ON LEFT HIP AND FACE. UPDATE: THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152276 ACCOLADE TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 19255801

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R