BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2021649 · Received March 10, 2011

    Report

    Report Number
    2249697-2011-00306
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 6260-9-240, LOT# EEKMKD, DESCRIPTION: V40 COCR LFIT HEAD 40MM/+4. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REVISED PATIENT DUE TO INFECTION, AFTER WASHOUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA UHMWTE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R