BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE PIECE CUP 38MM X 56 O.D.

    MDR report key: 2233493 · Received September 2, 2011

    Report

    Report Number
    1825034-2011-00765
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00765 / 00766). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO DISCOMFORT EXPERIENCED BY THE PATIENT. THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. 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 56 O.D. PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 898330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R