BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF HIP STEM #4

    MDR report key: 3233512 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02356
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN ACCOLADE TMZF HIP STEM #4 WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED OPERATIVE REPORTS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: ¿NEITHER THE INFECTION REQUIRING REVISION NOR THE BREAKAGE OF THE ACCOLADE INSERTER/EXTRACTOR WERE THE RESULT OF FACTORS OF FAULTY PROSTHETIC OR INSTRUMENT MANUFACTURING OR MATERIALS.¿ DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT OR STERILE LOT. CONCLUSIONS: A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 623-10-32E, LOT # 42166001, DESCRIPTION: TRIDENT 10° X3 INSERT 32MM ID; CAT # 500-11-54E, LOT # 41680201, DESCRIPTION: TRIDENT HEMISPHERICAL SOLID BACK SHELL; CAT # 6565-0-132, LOT # 42175101, DESCRIPTION: ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT A REVISION OF A WELL FIXED ACCOLADE STEM TOOK PLACE DUE TO INFECTION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED VIA THE SALES REP THAT A REVISION OF A WELL FIXED ACCOLADE STEM TOOK PLACE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334063 ACCOLADE TMZF HIP STEM #4 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 37350901

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R