BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT SHELL

    MDR report key: 6405853 · Received March 15, 2017

    Report

    Report Number
    0002249697-2017-00916
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    December 7, 2016
    Report Date
    March 15, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A MALPOSITION INVOLVING AN UNKNOWN TRIDENT SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE REMAINS IMPLANTED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "CUP MALPOSITION IN EXCESSIVE INCLINATION CAUSED LOCAL OVERLOAD WITH HIGH PEAK CONTACT FORCES IN THE CERAMIC ARTICULATION AND CONSEQUENTLY A CERAMIC HEAD FRACTURE." DEVICE HISTORY REVIEW: A DHR REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT ID IS UNKNOWN. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED "CUP MALPOSITION IN EXCESSIVE INCLINATION CAUSED LOCAL OVERLOAD WITH HIGH PEAK CONTACT FORCES IN THE CERAMIC ARTICULATION AND CONSEQUENTLY A CERAMIC HEAD FRACTURE". NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, INCLUDING DEVICE DETAILS, THIS INVESTIGATION WILL BE RE-OPENED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A RIGHT HIP REVISION SURGERY WAS CARRIED OUT ON A PATIENT BECAUSE THE ALUMINA HEAD HAD FRACTURED. PATIENT WAS BENDING FORWARD TO GET MILK OFF A SHELF. NO PRECEDING TRAUMA/FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188196 UNKNOWN TRIDENT SHELL HIP IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R