BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION T3 REVISION HIP SYSTEM

    MDR report key: 510386 · Received February 4, 2004

    Report

    Report Number
    9616680-2004-00006
    Event Type
    Injury
    Date Received
    February 4, 2004
    Report Date
    January 8, 2004
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD A T3 COMPONENT IMPLANTED IN 2002. IN 2003, THE PT WAS TACKLED BY A PRISONER, THEY BOTH FELL AND AT THIS TIME IT IS BELIEVED THAT THE T3 STEM WAS BROKEN. REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORATION T3 REVISION HIP SYSTEM IMPLANT JDI STRYKER HOWMEDICA OSTEONICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention