BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM PF CUP 58MM OD X 52MM ID

    MDR report key: 2011057 · Received March 8, 2011

    Report

    Report Number
    1825034-2011-00154
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 6, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS." "PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." EVALUATION OF THE RETURNED COMPONENT FOUND THE POROUS COATING ON THE CUP APPEARED TO BE INTACT BUT SHOWED LITTLE EVIDENCE OF BONY INGROWTH. THE BEARING SURFACE APPEARED TO SHOW EVIDENCE OF DAMAGE DUE TO SUBLUXATION OF THE JOINT. THE BEARING SURFACE EXHIBITED WEAR, APPARENTLY DUE TO A THIRD BODY MATERIAL TRAPPED IN THE CLEARANCE. BASED UPON THE APPEARANCE OF THE PART, WEAR RATES DID NOT APPEAR TO BE EXCESSIVE. ALTHOUGH IT APPEARS THAT SOME TYPE OF THIRD BODY PARTICLE WAS PRESENT, THE SOURCE AND IDENTITY OF THIS AGENT COULD NOT BE ESTABLISHED DURING VISUAL EXAMINATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON MARCH 7, 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. THIS REPORT FILED MARCH 8, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO METALLOSIS AND LACK OF BONE INGROWTH. THE SURGEON NOTED THERE WAS TISSUE REACTION. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM PF CUP 58MM OD X 52MM ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 669160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R