BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #2

    MDR report key: 3071399 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01357
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A ACCOLADE PLUS TMZF HIP STEM #2 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION INDICATED THAT DAMAGE WAS NOTED TO BOTH ANTERIOR AND POSTERIOR SURFACES AT THE COATED AREA AND PROXIMAL AREA OF THE IMPLANT. THIS DAMAGE IS KNOWN TO BE ASSOCIATED WITH EXPLANTATION OF THE DEVICE. SOME BONY ON-GROWTH WAS OBSERVED ON THE COATED SURFACE OF THE RETURNED STEM. ALSO ADHERED DEBRIS AND DARK DISCOLORATION WAS SEEN AT THE TRUNNION AND SLIGHTLY BELOW THE DISTAL EDGE OF THE TRUNNION. THE MATERIAL ANALYSIS OF THE STEM CONCLUDED THAT THE "DEBRIS COMPOSITION WAS CONSISTENT WITH A CORROSION PRODUCT". NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE STEM. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT:TRIDENT HEMISPHERICAL SOLID BACK SHELL, CAT # 500-11-56F, LOT # 27762601;INSERT LINER X3 NEUTRAL, CAT # UNKNOWN, LOT # UNKNOWN.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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 RIGHT HIP TODAY OF INFECTED JOINT. FOUND CORROSION ON AND BELOW TRUNION. REMOVED ALL FOUR PIECES AND PUT IN ANTIBIOTIC SPACERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DID A REVISION OF RIGHT HIP TODAY OF INFECTED JOINT. FOUND CORROSION ON AND BELOW TRUNNION. REMOVED ALL FOUR PIECES AND PUT IN ANTIBIOTIC SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171272 ACCOLADE PLUS TMZF HIP STEM #2 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 26125706

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O| R