BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR LINER

    MDR report key: 91340 · Received May 13, 1997

    Report

    Report Number
    1825034-1997-00035
    Event Type
    Injury
    Date Received
    May 13, 1997
    Date of Event
    March 8, 1996
    Report Date
    May 13, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL MEDWATCH REPORT STATED THE LOT NUMBER OF THE SUBJECT DEVICE INCORRECTLY AS 790010. THE ACTUAL LOT NUMBER OF THE SUBJECT DEVICE IS 790110.

    Description of Event or Problem · 1

    TOTAL HIP ARTHROPLASTY WAS PERFORMED ON 11/20/91. REVISION SURGERY WAS PERFORMED ON 3/8/96, DUE TO FRACTURE OF ACETABULAR LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR LINER Implant PROSTHESIS, HIP, COMP. KWB BIOMET, INC. NA 790110

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R