BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS

    MDR report key: 385639 · Received March 29, 2002

    Report

    Report Number
    385639
    Event Type
    Injury
    Date Received
    March 29, 2002
    Date of Event
    February 13, 2002
    Report Date
    February 20, 2002
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF UNICOMPARTMENTAL KNEE IMPLANT REQUIRING SURGICAL REPLACEMENT/REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS REPICCI II HSH BIOMET ORTHOPEDICS REPPICCI II 5/64 X2 955020
    2 BIOMET ORTHOPEDICS REPICCI II HRY BIOMET ORTHOPEDICS REPPICCI II 5/64 X2 920670

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention