BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 44MM

    MDR report key: 3180755 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02066
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    September 19, 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
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02066 / 02068).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, ADVERSE REACTION TO METAL DEBRIS, ELEVATED COCR LEVELS AND TISSUE AND BONE DESTRUCTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 AND WAS DUE TO ELEVATED METAL ION LEVELS, LOOSE ACETABULAR CUP, SYNOVITIS AND LYSIS. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, ADVERSE REACTION TO METAL DEBRIS, ELEVATED COCR LEVELS AND TISSUE AND BONE DESTRUCTION. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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
    280137 M2A-MAGNUM MODULAR HEAD SIZE 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 843220

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R