BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 28MM HEAD DIAMETER

    MDR report key: 2060177 · Received April 15, 2011

    Report

    Report Number
    1825034-2011-00272
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K993438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT FOUND THE BEARING SURFACE SHOWED RANDOM AND APPROXIMATELY PARALLEL SETS OF SCRATCHES OR INDENTATIONS. THERE WAS NO EVIDENCE OF CHANGES IN SURFACE CONTOUR AT THE EDGES OF THE CONTACT AREA. THE BACKSIDE OF THE MODULAR HEAD SHOWED LITTLE EVIDENCE OF DAMAGE. THE MORSE TAPER SHOWED EVIDENCE OF WEAR FROM CONTACT WITH THE STEM. BASED UPON THE APPEARANCE OF THE COMPONENT, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011 DUE TO PATIENT CONCERN OF METAL IONS. THE SURGEON NOTED DURING THE REVISION THAT THE COMPONENTS WERE WELL FIXED AND THERE WAS NO SIGN OF METAL DEBRIS. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 28MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 861510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R