BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 1920247 · Received December 10, 2010

    Report

    Report Number
    1825034-2010-00655
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NEEDED TO REVIEW DEVICE MANUFACTURING HISTORY RECORDS WAS UNAVAILABLE. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE WHICH REPORTED THAT A PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND WAS SUBSEQUENTLY REVISED DUE TO ACUTE PAIN. THE ONSET OF PAIN WAS APPROXIMATELY THREE MONTHS AFTER THE INITIAL SURGERY. RADIOGRAPHS WERE TAKEN AND NO LOOSENING OR MIGRATION OF THE COMPONENTS WAS NOTED. THE HIP WAS ASPIRATED AND NONVISCOUS FLUID WAS EXTRACTED. DURING THE REVISION PROCEDURE, A LARGE THICK-WALLED CYST CONSISTENT WITH A PSEUDOTUMOR WAS REMOVED. THE ACETABULAR CUP AND MODULAR HEAD WERE ALSO REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R