BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3970102 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02930
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 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

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT 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. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT HAS PAIN IN RIGHT HIP, REMOVED 36 0 DEGREE LINER AND REPLACED WITH 32 ELEVATED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446714 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention