BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 3100565 · Received May 8, 2013

    Report

    Report Number
    0001825034-2013-01312
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    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. 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." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01721-1 & 2013-01311/1312).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY BLOOD TEST RESULTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01721 & 2013-01311 / 01312).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL ALLEGES PATIENT ALLEGATIONS OF PAIN, ELEVATED COCR LEVELS, AND TISSUE/BONE DESTRUCTION. IT IS UNKNOWN WHETHER A REVISION PROCEDURE HAS OCCURRED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    200920 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 993980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R