BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MODULAR HEAD 40MM -3

    MDR report key: 3221169 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02615
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    December 3, 2014
    Report Date
    May 23, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY LABORATORY RESULTS, WHICH WERE UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2013-02613 / 02615). NOT RETURNED BY ATTORNEY.

    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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02613 / 02616).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A RIGHT REVISION PROCEDURE OCCURRED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, AND ELEVATED CHROMIUM AND COBALT LEVELS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 THE PATIENT REPORTS THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, AND ELEVATED CHROMIUM AND COBALT LEVELS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. IT WAS REPORTED IN OPERATIVE NOTES RECEIVED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY FIVE (5) YEARS POST-IMPLANTATION DUE TO PAIN, MECHANICAL SYMPTOMS AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, METALLOSIS, WELL-FIXED CUP AND STEM, BROWN STAINED VISCOUS LIQUID, METAL-STAINED SYNOVIUM AND LYSIS IN THE ILIUM WERE NOTED. THE MODULAR HEAD WAS REMOVED AND REPLACED WITH A POLY BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320113 SELEX/MAGNUM MODULAR HEAD 40MM -3 PROSTHESIS, HEAD LZO BIOMET ORTHOPEDICS N/A 649470

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R