BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY COLLARED TROCHANTERIC HA COATED MODULE

    MDR report key: 77473 · Received March 18, 1997

    Report

    Report Number
    1043534-1997-00027
    Event Type
    Injury
    Date Received
    March 18, 1997
    Date of Event
    January 27, 1997
    Report Date
    March 17, 1997
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION STATEMENT: THERE WAS NO DEVICE FAILURE. THREE REPORTS OF THE USER FACILITY BUT NO MEDWATCH FORM HAS BEEN RECEIVED. PRODUCT WAS MFR AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.

    Description of Event or Problem · 1

    FEMORAL PROSTHESIS DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY COLLARED TROCHANTERIC HA COATED MODULE Implant HIP COMPONENT -DEVICE 2 JDI WRIGHT MEDICAL TECHNOLOGY, INC. NA M752410

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention