BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE-PIECE CUP 38MM X 54 O.D.

    MDR report key: 1871731 · Received October 15, 2010

    Report

    Report Number
    1825034-2010-00427
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    February 25, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A SURGEON CONFERENCE PRESENTATION, REVISION PROCEDURES RELATED TO BIOMET PRODUCT WERE BEING DISCUSSED. SUBSEQUENTLY, BIOMET CONTACTED THE SURGEON'S OFFICE TO OBTAIN MORE DETAILED INFORMATION REGARDING THE EVENTS DISCUSSED DURING THE CONFERENCE. IT WAS CONFIRMED THAT BIOMET HAD NOT BEEN NOTIFIED OF THE EVENTS AND INFORMATION WAS SUPPLIED TO BIOMET ON SEPTEMBER 22, 2010. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION INDICATES DEVICES WERE STERILIZED IN ACCORDANCE WITH BIOMET PROCEDURES. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: POSSIBLE ADVERSE EFFECT - EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH UROSEPSIS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010, DUE TO INFECTION OF THE HIP. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED. THE WOUND WAS IRRIGATED AND A CEMENT SPACER WAS PLACED IN THE ACETABULUM. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM ONE-PIECE CUP 38MM X 54 O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 716710

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R