BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 36MM ID

    MDR report key: 1993477 · Received February 8, 2011

    Report

    Report Number
    2249697-2011-00104
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    October 25, 2010
    Report Date
    November 2, 2010
    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 (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6260-9-336, LOT #MJKJVL, DESCRIPTION: V40 COCR LFIT HEAD 36MM/+10. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "A STUDY SUBJECT ENROLLED IN THE TRIDENT TRITANIUM ACETABULAR SHELL REVISION STUDY (B)(4) HAD PREVIOUS IMPLANTS MANUFACTURED BY (B)(4). THESE COMPONENTS WERE SUBSEQUENTLY 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 MJJ7EV

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R