BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD CON DIST STEM 18 X 195 MM

    MDR report key: 3926407 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02615
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A RESTORATION MODULAR STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. MEDICAL RECORDS RECEIVED AND EVALUATION. INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. 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 AND STERILE LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT:CAT # 6276-1-329, LOT # 42139401, DESCRIPTION: 29MM MOD REV HIP BDY/BLT +30MMCOMPONENT LEVEL 9006-1-329.CAT # 6570-0-736, LOT # 42641602, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/+7,5.IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION OF LEFT HIP DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION OF LEFT HIP DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404955 MOD CON DIST STEM 18 X 195 MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH CAXN254D

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R