BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER

    MDR report key: 1912972 · Received December 2, 2010

    Report

    Report Number
    1825034-2010-00632
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    December 9, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - THE REVISION SURGERY IS SCHEDULED FOR (B)(6), 2010.THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE HAD NOT TAKEN PLACE AT THE TIME THE INITIAL MEDWATCH REPORT WAS FILED. BIOMET RECEIVED RECENT INFORMATION WHICH INCLUDED RADIOGRAPHIC IMAGES AND PATIENT NOTES PERTAINING TO PATIENT FOLLOW UP VISITS, LABORATORY TESTING AND THE REVISION PROCEDURE. THE INFORMATION RECEIVED WAS REVIEWED BY A BIOMATERIALS SCIENTIST. THE VISUAL INTERPRETATION OF THE RADIOGRAPHS REVEALED THAT THE ACETABULAR CUP WAS SLIGHTLY VERTICAL AND SLIGHTLY ANTEVERTED. THE PATIENT NOTES STATE "DEEP ACETABULAR POSITIONING", WHICH COULD LEAD TO SUBLUXATION OR EDGE WEAR ON THE COMPONENTS. HOWEVER, NO CONCLUSIONS CAN BE DRAWN AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. EVENT DESCRIPTION: WAS UPDATED TO INCLUDE THE INFORMATION REGARDING THE REVISION PROCEDURE THAT TOOK PLACE. RELEVANT TESTS/LAB DATA: UPDATED TO INCLUDE INFORMATION FROM THE NOTES PERTAINING TO PATIENT FOLLOW UP VISITS. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "MATERIAL SENSITIVITY REACTIONS. IMPLANTATION OF FOREIGN MATERIAL IN TISSUES MAY RESULT IN HISTOLOGICAL REACTIONS INVOLVING VARIOUS SIZES OF MACROPHAGES AND FIBROBLASTS." "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT FILED MARCH 29, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2006. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INCREASING SQUEAKING SOUND. A REVISION PROCEDURE IS PLANNED FOR (B)(6), 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INCREASING SQUEAKING SOUND. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 AND THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THE SURGEON NOTED METALLOSIS AND REMOVED IT ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 995270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R