BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 2840760 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02468
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 10, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION OF BLOOD TESTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02463-1 / 02468-1).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). REVIEW OF MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE AND THE DEVICES LIKELY LEFT THE MANUFACTURER CONFORMING TO PRINT. ALL COMPONENTS EXAMINED WERE NOTED TO HAVE SCRATCHES AND VARIOUS DEGREES OF OTHER DAMAGE, HOWEVER, THIS DAMAGE WAS MOST LIKELY CAUSED BY EXTRACTION INSTRUMENTS DURING THE REVISION PROCEDURE. COMPONENTS ALSO HAD EVIDENCE OF NATURAL WEAR. DIMENSIONAL ANALYSIS WAS PERFORMED ON MODULAR HEADS AND ACETABULAR SHELLS, WHICH REVEALED THE ARTICULAR SURFACES WERE OVERSIZE TO PRINT TOLERANCE DUE TO NATURAL SURFACE WEAR AFTER 6 YEARS OF IMPLANTATION A CONCLUSIVE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    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. 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02463 / 02468). THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT BILATERAL M2A HIP ARTHROPLASTY. LEFT SIDE WAS PERFORMED ON (B)(6) 2006 AND THE RIGHT SIDE ON (B)(6) 2006. SUBSEQUENTLY, PATIENT ALLEGES PAIN AND ELEVATED METAL IONS. A LEFT SIDE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 AND THE RIGHT SIDE REVISION ON (B)(6) 2012. THE CUP, HEAD AND ADAPTER WERE REMOVED AND REPLACED IN BOTH LEFT AND RIGHT REVISIONS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 722020

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R