BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM TAPER ADAPTER

    MDR report key: 2120554 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00493
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 17, 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 THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER FOURTEEN STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN" AND NUMBER FIFTEEN STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES". THE MODULAR HEAD AND TAPER ADAPTER WERE STILL ASSEMBLED AND NO ATTEMPT WAS MADE TO SEPARATE THESE COMPONENTS. THE TAPER ADAPTER SHOWED EVIDENCE OF LIGHT WEAR FROM CONTACT WITH THE STEM IN ONE LOCATION. HOWEVER, THE ORIGINAL MANUFACTURING MACHINING LINES WERE STILL VISIBLE ON THE TAPER. 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 (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011, DUE TO PAIN, MECHANICAL SYMPTOMS INCLUDING WEAKNESS AND LARGE CLUNK, AND ELEVATED COBALT AND CHROMIUM LEVELS. THE ACETABULAR CUP, MODULAR HEAD, AND TAPER ADAPTER WERE ALL REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A MAGNUM TAPER ADAPTER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 802230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R