BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD STD

    MDR report key: 3221194 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02624
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 12, 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
    AL, 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 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." AND NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02621 / 02625). 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 BILATERAL TOTAL HIP ARTHROPLASTY PROCEDURES AND REPORTS ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, METALLOSIS, TISSUE/BONE DESTRUCTION, LACK OF MOBILITY, DISCOMFORT AND DIFFICULTY WALKING. REVIEW OF INVOICE HISTORY CONFIRMS TOTAL HIP ARTHROPLASTY PROCEDURES OCCURRED ON LEFT SIDE (B)(6) 2008 AND RIGHT SIDE (B)(6) 2009. REVIEW OF INVOICE HISTORY CONFIRMS REVISION PROCEDURES WERE PERFORMED ON LEFT SIDE (B)(6) 2010, AND RIGHT SIDE (B)(6) 2013. THE HEADS AND TAPER ADAPTERS WERE REMOVED AND REPLACED. REVIEW OF INVOICE HISTORY ADDITIONALLY FOUND A REVISION PROCEDURE PERFORMED ON (B)(6) 2010, ON UNKNOWN SIDE DUE TO UNKNOWN REASON. THIS COMPLAINT 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
    319649 36MM COCR MOD HD STD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 679420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R