BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 28MM ID

    MDR report key: 3022595 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01070
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    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

    THE C-TAPER COCR LFIT HEAD 28MM/0, CAT# 06-2800, LOT# UNK WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S FALL. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS REPORTED DEVICE AND PATIENT MEDICAL RECORDS WERE NOT PROVIDED FOR EVALUATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO MINIMAL INFORMATION PROVIDED, HOWEVER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRAUMA WHICH LED TO THE REVISION. TRAUMA IS A KNOWN ADVERSE EFFECT AND THIS EVENT IS MOST LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    DR (B)(6) REVISED HIP BECAUSE PATIENT FELL AND BROKE THEIR LEG REQUIRING CABLES AND A PLATE.

    Description of Event or Problem · 1

    DR.(B)(6). REVISED HIP BECAUSE PATIENT FELL AND BROKE THEIR LEG REQUIRING CABLES AND A PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125975 TRIDENT 10° X3 INSERT 28MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention