BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER

    MDR report key: 2120865 · Received June 11, 2011

    Report

    Report Number
    1825034-2011-00500
    Event Type
    Injury
    Date Received
    June 11, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." DATE OF EVENT - PATIENT BEGAN HAVING ISSUES TWO MONTHS POST-OP IN 2009. TO DATE, NO REVISION PROCEDURE HAS BEEN REPORTED. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE HIP ARTHROPLASTY ON (B)(6), 2009 AND SUBSEQUENTLY BEGAN EXPERIENCING ISSUES APPROXIMATELY TWO MONTHS POST-OPERATIVE. THE PATIENT FURTHER REPORTS EXPERIENCING PAIN, POPPING SENSATION AND A FEELING OF DISLOCATION. ADDITIONALLY, THE PATIENT REPORTS LIMITED MOVEMENT OF THE LEG. TO DATE, A REVISION PROCEDURE HAS NOT BEEN REPORTED. THE PATIENT REPORTS THAT SHE IS CONSIDERED "HIGH RISK" AND HER REGULAR SURGEON IS UNCERTAIN IF REVISION PROCEDURE IS AN OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD 44MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 534330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R