BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACH 11X200 100% POR FMRL STR

    MDR report key: 3787428 · Received May 2, 2014

    Report

    Report Number
    0001825034-2014-03545
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    October 30, 2007
    Report Date
    April 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK982367
    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 30 OF 30 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2010-00591-1 / 00598-1 AND 1825034-2013-04791/-04801 AND -04806 AND -04809 AND -04813/-04816 AND 1825034-2014-03541/-03545).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2007 TO IMPLANT A CABLE SYSTEM. THE STEM WAS REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT WAS REVISED (B)(6) 2007, DUE TO RECURRENT DISLOCATION, INSTABILITY, AND LOOSENING. OPERATIVE (OP) NOTES REPORT SUBSIDENCE OF THE FEMORAL COMPONENT CAUSING SHORTENING AND INSTABILITY. REVISION OP NOTES ALSO REPORT PRESENCE OF CLEAR FLUID AND A LOOSE CUP. THE ACETABULAR COMPONENT, POLYETHYLENE LINER, FEMORAL COMPONENT, MODULAR HEAD, LATERAL STRUT GRAFT, AND ALL SIX CABLES WERE REMOVED AND REPLACED. ON (B)(6) 2008, DUE TO INSTABILITY AND A PERIPROSTHETIC FEMUR FRACTURE. THE POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. THE SURGEON ALSO IMPLANTED A TROCHANTER CLAW, BOLT AND CABLE SYSTEM. THEN, ON (B)(6) 2008, PATIENT WAS REVISED DUE TO INSTABILITY AND DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. OPERATIVE NOTES STATE THE PRESENCE OF A HEMATOMA AND THAT THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2008, THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND THE ACETABULAR CUP, POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ALSO, THE FEMORAL STEM WAS REMOVED AND REPLACED WITH A COMPETITOR CEMENT SPACER MOLD. FINALLY, ON (B)(6) 2008, PATIENT UNDERWENT A STAGE TWO REVISION WHERE THE SURGEON REIMPLANTED TOTAL HIP COMPONENTS. THE MODULAR HEAD, ACETABULAR COMPONENT AND COMPETITOR CEMENT SPACER MOLD WERE REMOVED AND REPLACED. A REVIEW OF RADIOGRAPHIC IMAGES REVEALED THAT THE PATIENT IS BILATERAL. THEREFORE, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. RADIOGRAPHS SHOW THE BIOMET CUP HAS MIGRATED VERTICALLY. ADDITIONAL INFORMATION FROM THE PATIENT¿S LEGAL COUNSEL REPORTS PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6) 2014, DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY AND RANGE OF MOTION, SORENESS, DYSFUNCTION, AND ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. 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
    265577 REACH 11X200 100% POR FMRL STR PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 200920

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R