BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RINGLC LNR HW SZ24

    MDR report key: 3821683 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04382
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    July 10, 2012
    Report Date
    April 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-02230/-02231/-05037/-05038/-05039 & 2014-04382).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND REPORTS PATIENT ALLEGATIONS OF PAIN AND METAL DEBRIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATE A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO ACETABULAR CUP LOOSENING. REVISION OPERATIVE REPORT ALSO NOTED SOFT TISSUE REACTION CONSISTENT WITH METALLOSIS WITH A GRAYISH STAINING OF THE SOFT TISSUES AND FLUID COLLECTION. THE ACETABULAR CUP, MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE COMPLAINT REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO AN UNKNOWN REASON. THE ACETABULAR LINER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300784 EPOLY 36MM RINGLC LNR HW SZ24 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 209680

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R