BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM FLARED ONE-PIECE CUP 38MM ID X 60MM OD

    MDR report key: 1895120 · Received November 10, 2010

    Report

    Report Number
    1825034-2010-00511
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: POSSIBLE ADVERSE EFFECT #4 - LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY. POSSIBLE ADVERSE EFFECT #8 - DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN CONTRIBUTE TO THESE CONDITIONS. THIS REPORT FILED (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED COMPONENT FOUND EVIDENCE OF DEFORMATION OF THE RIM AND SCRATCHING OF THE BEARING SURFACE; WHICH WAS POSSIBLY FROM NECK IMPINGEMENT AND/OR LUXATION OF THE HEAD. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010 DUE TO LOOSENING OF THE ACETABULAR CUP AND DISLOCATION OF THE MODULAR HEAD. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED. THE MODULAR HEAD WAS NOT MANUFACTURED BY BIOMET ORTHOPEDICS. NO FURTHER INFORMATION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO LOOSENING OF THE ACETABULAR CUP AND DISLOCATION OF THE MODULAR HEAD. THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED. THE MODULAR HEAD WAS NOT MANUFACTURED BY BIOMET ORTHOPEDICS. NO FURTHER INFORMATION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM FLARED ONE-PIECE CUP 38MM ID X 60MM OD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 906800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R