BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MODULAR HEAD +9MM

    MDR report key: 3180546 · Received June 20, 2013

    Report

    Report Number
    0001825034-2013-02079
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY BLOOD TEST RESULTS WHICH WERE 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02079 & 02080). PREVIOUS MEDWATCH REPORTS WERE SUBMITTED FOR THIS PATIENT (1825034-2012-02478 / 02481). 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

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT M2A HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2010 ALLEGEDLY DUE TO ELEVATED METAL ION LEVELS, PAIN AND DIFFICULTY WALKING. A SECOND REVISION WAS ALLEGEDLY PERFORMED ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN THE FORM OF OPERATIVE NOTES INDICATE THAT THE REVISION ON (B)(6) 2010 WAS PERFORMED DUE TO ACETABULAR CUP LOOSENING. FURTHER INFORMATION RECEIVED IN OPERATIVE NOTES INDICATE THE REVISION PROCEDURE PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN. 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
    279544 36MM COCR MODULAR HEAD +9MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 434810

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R