BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM STD

    MDR report key: 3821921 · Received May 20, 2014

    Report

    Report Number
    0001825034-2014-04427
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    March 6, 2014
    Report Date
    November 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." 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 BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04427 / 04430).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED RIGHT HIP REVISION PROCEDURE 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 PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, ELEVATED METAL ION LEVELS AND METALLOSIS. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED RIGHT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO ELEVATED METAL ION LEVELS. REVISION OP REPORT NOTES THE PRESENCE OF METALLOSIS, TRUNIONOSIS, AN ANTEVERTED AND VERTICAL ACETABULAR COMPONENT, DEBRIS, AND TWO NECROTIC CYSTS IN THE ACETABULUM. THE HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300092 SELEX/MAGNUM MOD HD 40MM STD PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 945280

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R