BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-TAPER LINER SZ 41/32

    MDR report key: 3932476 · Received July 14, 2014

    Report

    Report Number
    0001825034-2014-06142
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 5, 2011
    Report Date
    June 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDL
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "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 1825034-2013-00928, 2014-03914 & 2014-06142).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF PAIN, TISSUE/BONE DESTRUCTION, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, SWELLING AND INFLAMMATION. ADDITIONALLY, (B)(6) 2011 OPERATIVE REPORT FOR THE RIGHT HIP REVISION NOTED THE REVISION WAS DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT AND TESTING RESULTS FURTHER NOTED THE PRESENCE OF LYSIS, FIBRINOUS MATERIAL, TAN-GRAY SOFT TO RUBBERY TISSUE WITH NO GROWTH PRESENT WHEN TESTED AND FLUID. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH A COMPETITOR¿S CUP AND A BIOMET HEAD. 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
    411393 M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A 170360

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R