BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPTER 12/14 TAPER 52-60MM

    MDR report key: 2160344 · Received July 13, 2011

    Report

    Report Number
    1825034-2011-00565
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 27, 2010
    Report Date
    June 16, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K061423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    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. 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).

    Additional Manufacturer Narrative · 1

    THE TAPER ADAPTER SHOWS EVIDENCE OF LIGHT WEAR FROM CONTACT WITH THE COMPETITOR-MADE STEM. WEAR RATES DID NOT APPEAR TO BE EXCESSIVE.THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND THAT A SUBSEQUENT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO INCREASING PAIN. PATIENT PROVIDED OPERATIVE REPORTS FOR BOTH THE PRIMARY SURGERY AND THE REVISION PROCEDURE. OPERATIVE REPORT NOTES FROM THE REVISION PROCEDURE INDICATE THAT THE SURGEON NOTED THE FEMORAL STEM WAS LOOSE AND THAT THERE WAS REACTIVE INFLAMMATION AROUND THE PROXIMAL STEM. THE SURGEON FURTHER NOTED THE ACETABULAR CUP TO BE WELL FIXED. ALL COMPONENTS WERE REMOVED AND REPLACED. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE BIOMET MANUFACTURED; HOWEVER, THE FEMORAL STEM WAS MANUFACTURED BY A COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TAPER ADAPTER 12/14 TAPER 52-60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 305900

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R