BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LNR SZ23

    MDR report key: 5323362 · Received December 23, 2015

    Report

    Report Number
    0001825034-2015-05143
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    September 24, 2014
    Report Date
    January 11, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 5 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05142-1 / 2015-05143-1 / 2015-05144-1 / 2016-00256 / 2016-00257).

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-05142 / 05143 / 05144).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN AND ELEVATED COBALT ION LEVELS. PATIENT WAS REVISED AGAIN ON (B)(6) 2013 DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND SPACERS WERE IMPLANTED. ON (B)(6) 2014, THE SPACERS WERE REMOVED AND PATIENT UNDERWENT RE-IMPLANTATION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2013, LOOSENING OF THE CUP, DISCOLORED JOINT FLUID, HYPERTROPHIC SYNOVIAL TISSUE, AND DEFICIENCY IN THE ANTERIOR WALL WERE NOTED. PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE BETWEEN (B)(6) 2013. ADDITIONAL INFORMATION FURTHER REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6) 2013, PURULENT FLUID AND DENUDED FATTY TISSUE SUGGESTIVE OF LONG TERM AND INFECTED HEMATOMA WERE NOTED. A TROCHANTERIC OSTEOTOMY WAS PERFORMED TO REMOVE THE WELL FIXED STEM AND A PIECE OF MEDIAL CALCAR FRACTURED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO ALLEGATIONS OF PAIN AND ELEVATED COBALT ION LEVELS. PATIENT WAS REVISED AGAIN ON (B)(6) 2013 DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND SPACERS WERE IMPLANTED. ON (B)(6) 2014, THE SPACERS WERE REMOVED AND PATIENT UNDERWENT RE-IMPLANTATION. 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
    847029 E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 073690

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R