BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CONSTRAINED INSERT

    MDR report key: 3984259 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03038
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    P960047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO DR. (B)(6) WITH A DISLOCATED RIGHT HIP. PATIENT HAD A STRYKER CONSTRAINED LINER IMPLANTED IN 2006. AFTER EXPLANTING THE LINER IT WAS OBSERVED THE LINER HAD FRACTURED. THE LINER WAS REPLACED WITH AN MDM LINER AND CORRESPONDING INSERT. THE STEM WAS A DEPUY IMPLANT.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO DR (B)(6) WITH A DISLOCATED RIGHT HIP. PATIENT HAD A STRYKER CONSTRAINED LINER IMPLANTED IN 2006. AFTER EXPLANTING THE LINER, IT WAS OBSERVED THE LINER HAD FRACTURED. THE LINER WAS REPLACED WITH AN MDM LINER AND CORRESPONDING INSERT. THE STEM WAS A DEPUY IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461698 TRIDENT CONSTRAINED INSERT IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH 3DDMLA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention