BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T UNIV 2-HOLE SHELL SZ 41/52

    MDR report key: 2924433 · Received January 22, 2013

    Report

    Report Number
    0001825034-2013-00134
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    February 14, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY BLOOD TESTS, WHICH 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, 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 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00133 / 00135).

    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. 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00133 / 00135). 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 ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2002. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 AND THE CUP, HEAD, AND TAPER ADAPTER WERE REMOVED AND REPLACED. 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
    31057 M2A-T UNIV 2-HOLE SHELL SZ 41/52 PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 057060

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R