BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38-MM MODULAR HEAD- UNK

    MDR report key: 2696951 · Received August 14, 2012

    Report

    Report Number
    0001825034-2012-01284
    Event Type
    Injury
    Date Received
    August 14, 2012
    Report Date
    July 22, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL NAME OF THE JOURNAL ARTICLE IS "FAILED METAL-ON-METAL TOTAL HIP ARTHROPLASTY PRESENTING AS PAINFUL GROIN MASS WITH ASSOCIATED WEIGHT LOSS AND NIGHT SWEATS" FROM THE AMERICAN JOURNAL OF ORTHOPEDICS COPYRIGHT QUADRANT HEALTHCOM INC. 2010 THE PRODUCT AND LOT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENTS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01283/ 001284.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENT UNDERWENT M2A LEFT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE ALLEGEDLY DUE TO LOOSE ACETABULAR COMPONENT AND GROIN MASS. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38-MM MODULAR HEAD- UNK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R