BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #3

    MDR report key: 3023869 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01108
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION AND MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2051-3056, LOT # 59579901, DESCRIPTION: SECUR-FIT HA SCREWLESS CUP 56MM; CAT # 2041C-2854, LOT # 59300101, DESCRIPTION: CROSSFIRE 10 DEG INSERT; CAT # 6264-5-528, LOT # C1HMA9503001, DESCRIPTION: 28MM +16 5-40 TAPER VIT HEAD OBSOLETE RUTHERFORD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DID A REVISION OF THE PRIMARY HIP DONE IN 2001. THE REASON FOR THE REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DID A REVISION OF THE PRIMARY HIP DONE IN 2001. THE REASON FOR THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127061 ACCOLADE TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 1519401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention