BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 4221901 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04169
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    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 UPON COMPLETION OF THE INVESTIGATION. NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS DISLOCATING ON LEFT HIP. DOCTOR REVISED PATIENT TO CONSTRAINED LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS DISLOCATING ON LEFT HIP. DOCTOR REVISED PATIENT TO CONSTRAINED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701829 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MNJ0H1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R