BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 36MM ID

    MDR report key: 2002512 · Received February 16, 2011

    Report

    Report Number
    2249697-2011-00164
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY STRYKER ORTHOPAEDICS CLINICAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6265-5112, LOT # 31095402, DESCRIPTION: CITATION TMZF HA STEM #2 RIGHT. CAT # 6570-0-136, LOT # 32148401, DESCRIPTION: DELTA V-40 CERAMIC HEAD 36/0. CAT # 500-11-52E, LOT # 31368501, DESCRIPTION: TRIDENT HEMISPHERICAL SOLID BACK SHELL. 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 A CASE ENROLLED IN THE TRIDENT TRITANIUM ACETABULAR SHELL REVISION STUDY (B)(4) HAD PREVIOUS IMPLANTS MANUFACTURED BY STRYKER. THE PREVIOUS IMPLANTS WERE NOTED AS REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MJA67W

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R