BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR LINER, 10DEG/HI-WALL

    MDR report key: 103044 · Received June 20, 1997

    Report

    Report Number
    1825034-1997-00045
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    April 17, 1997
    Report Date
    June 13, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMET, INC. RECEIVED A MEDWATCH REPORT FROM THE USER FACILITY ON 7/2/1997. THE FOLLOW-UP IS FOR ADDITIONAL INFO FROM THE USER FACILITY. ON THE USER FACILITIES MEDWATCH REPORT, THEY STATE THAT THE DEVICE WAS RETURNED TO BIOMET, INC. ON 4/17/1997. THE DEVICE WAS RETURNED TO BIOMET ON 5/5/1997.

    Description of Event or Problem · 1

    PT HAD TO HAVE REVISION OF ACETABULAR COMPONENT LEFT HIP AS A RESULT OF THE ACETABULAR COMPONENT BECOMING FRACTURED. IT HAD BEEN IMPLANTED IN 1992.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR LINER, 10DEG/HI-WALL Implant PROSTHESIS, HIP, ACETABULAR COMPONENT KWB BIOMET, INC. NA 567870

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R