BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 2991079 · Received March 6, 2013

    Report

    Report Number
    0002249697-2013-00921
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 8, 2008
    Report Date
    February 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING PAIN RELATED TO A TRIDENT ACETABULAR LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE REMAINS IMPLANTED. MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF THE PROVIDED RECORDS CONCLUDED: "BASED UPON THE INFORMATION REVIEWED NO DETERMINATION CAN BE MADE REGARDING THIS CLINICAL SITUATION." DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW WAS NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS TROUBLE WALKING AND FALLS REGULARLY. PATIENT CANNOT WALK LONG DISTANCES. PATIENT STATES THAT THE HIP POPS AND CATCHES WHEN SHE TURNS ON IT. PATIENT IS CONSTANTLY IN A LOT OF PAIN AND REGULARLY TAKES PAIN MEDICATION. PATIENT IS SEDENTARY WITH IMPAIRED MOBILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS TROUBLE WALKING AND FALLS REGULARLY. PATIENT CANNOT WALK LONG DISTANCES. PATIENT STATES THAT THE HIP POPS AND CATCHES WHEN SHE TURNS ON IT. PATIENT IS CONSTANTLY IN A LOT OF PAIN AND REGULARLY TAKES PAIN MEDICATION. PATIENT IS SEDENTARY WITH IMPAIRED MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95141 TRIDENT 0° X3 INSERT 36MM ID IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH XM9MNE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other