BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 3140709 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01837
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 542-11-46D, LOT # 35105901A, DESCRIPTION: TRIDENT PSL WITH PUREFIX HA 46MM; CAT # 6260-9-132, LOT # UNKNOWN, DESCRIPTION: 32MM STD LFIT V40 HEAD; CAT # 2030-6520-1, LOT # 41JMAD, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 20MM; CAT # 2030-6535-1, LOT # MV9MDD, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 35MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO DISCOMFORT INVOLVING A TRIDENT 10 DEGREE INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    REMOVED TRIDENT PSL CUP 46D, 2 CANCELLOUS SCREWS, TRIDENT X3 32MM 10 DEGREE LINER, AND 32 MM V40 METAL HEAD. PATIENT HAD COMPLAINTS OF DISCOMFORT FOR LONG PERIOD OF TIME. REPLACED WITH TRITANIUM CUP, MDM LINER, MDM INSERT, AND LFIT HEAD.

    Description of Event or Problem · 1

    REMOVED TRIDENT PSL CUP 46D, 2 CANCELLOUS SCREWS, TRIDENT X3 32MM 10 DEGREE LINER, AND 32 MM V40 METAL HEAD. PATIENT HAD COMPLAINTS OF DISCOMFORT FOR LONG PERIOD OF TIME. REPLACED WITH TRITANIUM CUP, MDM LINER, MDM INSERT, AND LFIT HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241629 TRIDENT 10° X3 INSERT 32MM ID IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH N8KMMD

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention