BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO II MOD ENDO HEAD SZ 48

    MDR report key: 3802956 · Received May 9, 2014

    Report

    Report Number
    0001825034-2014-03797
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 4, 2013
    Report Date
    July 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK984028
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03791 /-03792 /- 03797).

    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 ASSOCIATED 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 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03791 / 03792, 0397).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2008, (B)(6) 2008, (B)(6) 2012, AND (B)(6) 2013. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL PROCEDURE AND THE REVISION DATES OF (B)(6) 2012, AND (B)(6) 2013. 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 PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN, INFLAMMATION, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, AND METALLOSIS. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2008, (B)(6) 2012, AND (B)(6) 2013. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL PROCEDURE AND THE REVISION DATES OF (B)(6) 2012, AND (B)(6) 2013. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT RECEIVED NOTED PATIENT UNDERWENT A RIGHT HIP REVISION ON (B)(6) 2008 WHERE THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED. OP REPORT NOTED THE PRESENCE OF DEEP SCAR TISSUE AND A SYNOVIAL CYST. THE MODULAR HEAD WAS REIMPLANTED ON (B)(6) 2008. OPERATIVE REPORT FOR THE (B)(6) 2012 REVISION NOTED THE PRESENCE OF DEBRIS, SCAR TISSUE, AND A PSEUDOCAPSULE. ALL COMPONENTS WERE REMOVED AND A MODULAR HEAD AND SPACER MOLDS WERE IMPLANTED. THE MODULAR HEAD WAS REMOVED AND REPLACED ON THE (B)(6) 2013 REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280732 ENDO II MOD ENDO HEAD SZ 48 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 122400

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R