BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 4241390 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04222
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. A REVIEW OF THE PROVIDED X-RAY BY A CLINICAL CONSULTANT CONFIRMED THE DISLOCATION THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE 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

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REVISION OF LEFT HIP DUE TO CHRONIC DISLOCATION. HEAD AND LINER WAS REVISED.

    Description of Event or Problem · 1

    REVISION OF LEFT HIP DUE TO CHRONIC DISLOCATION. HEAD AND LINER WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722126 TRIDENT 0 DEG INSERT 36MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLMT0D

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention