BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 3182965 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02142
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    October 18, 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
    GA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿

    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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02141 / 02142).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, TISSUE/BONE DESTRUCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. 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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, TISSUE/BONE DESTRUCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION WAS RECEIVED IN PATIENT MEDICAL RECORDS FOR THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2013. REVISION OPERATIVE REPORT NOTES PRESENCE OF BLACK AND GRAY METALLOSIS AND DIFFICULTY REMOVING THE MODULAR HEAD. MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282790 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 920640

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R