BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELEX/MAGNUM MOD HD 40MM STD

    MDR report key: 3830591 · Received May 23, 2014

    Report

    Report Number
    0001825034-2014-04583
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    July 30, 2013
    Report Date
    June 1, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04583 & 04584 & 1825034-2015-02569 & 02571 & 02572).

    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.

    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. 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. IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." 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." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - (B)(6) 2013 OR (B)(6) 2013; DATE EXPLANTED - (B)(6) 2013 OR (B)(6) 2013. 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04583 / 04584).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6), 2009. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, OSTEOLYSIS, NAUSEA, LIGHTHEADEDNESS, FATIGUE, BLURRED VISION, LEG TREMORS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD WAS REMOVED AND REPLACED IN BOTH REVISION PROCEDURES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF铠COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAIN. OP REPORT NOTES THE PRESENCE OF SCAR TISSUE BETWEEN THE FEMORAL HEAD AND INSIDE THE CUP, NO TISSUE DISCOLORATION, NO CYST FORMATION, NO SIGNS OF INFECTION, AND NO SIGNS OF LOOSENING. ADDITIONAL INFORMATION RECEIVED IN PATIENT OP NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO MECHANICAL SYMPTOMS OF LOCKING AND CATCHING. OP REPORT FURTHER NOTES THE PRESENCE OF SCAR TISSUE, BUT ALL COMPONENTS WERE STABLE. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT WAS REVISED ON THE LEFT SIDE ON (B)(6) 2014 DUE TO DISLOCATION. THE ACETABULAR CUP, LINER, AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP AND LINER. ADDITIONALLY, PATIENT WAS REVISED AGAIN ON THE LEFT SIDE ON (B)(6) 2015 DUE TO DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, OSTEOLYSIS, NAUSEA, LIGHTHEADEDNESS, FATIGUE, BLURRED VISION, LEG TREMORS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD WAS REMOVED AND REPLACED IN BOTH REVISION PROCEDURES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAIN. OP REPORT NOTES THE PRESENCE OF SCAR TISSUE BETWEEN THE FEMORAL HEAD AND INSIDE THE CUP, NO TISSUE DISCOLORATION, NO CYST FORMATION, NO SIGNS OF INFECTION, AND NO SIGNS OF LOOSENING. ADDITIONAL INFORMATION RECEIVED IN PATIENT OP NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO MECHANICAL SYMPTOMS OF LOCKING AND CATCHING. OP REPORT FURTHER NOTES THE PRESENCE OF SCAR TISSUE, BUT ALL COMPONENTS WERE STABLE.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, OSTEOLYSIS, NAUSEA, LIGHTHEADEDNESS, FATIGUE, BLURRED VISION, LEG TREMORS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD WAS REMOVED AND REPLACED IN BOTH REVISION PROCEDURES. 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
    308384 SELEX/MAGNUM MOD HD 40MM STD PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 899220

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R