BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD SIZE 48MM

    MDR report key: 2083357 · Received May 10, 2011

    Report

    Report Number
    1825034-2011-00364
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND USER FACILITY REPORT NUMBER REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. THIS REPORT FILED (B)(4), 2011.

    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. EVALUATION OF THE RETURNED COMPONENT FOUND THAT IT WAS STILL ASSEMBLED WITH THE TAPER ADAPTER AND NO ATTEMPT WAS MADE TO SEPARATE THE COMPONENTS. THE MODULAR HEAD COMPONENT APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES. BASED ON 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 THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THE STEM WAS WELL FIXED AND REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM MODULAR HEAD SIZE 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 108210

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R