BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HEAD +9MM

    MDR report key: 3833275 · Received May 27, 2014

    Report

    Report Number
    0001825034-2014-04786
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2008
    Report Date
    April 28, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿ NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 1 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04786 / 04791, 04799).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND REVISION PROCEDURES ON (B)(6) 2005, (B)(6) 2008, (B)(6) 2009, (B)(6) 2009, (B)(6) 2009, AND DECEMBER 9, 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND A REVISION PROCEDURE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. 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
    310668 36MM COCR MOD HEAD +9MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 523180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R