BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 3970497 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06635
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    June 2, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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 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 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06635 & -2015-02660).

    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.¿ 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 AN UNKNOWN DATE. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. 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 AN UNKNOWN DATE. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT REVISION PROCEDURE ON (B)(6) 2014 DUE TO A PAINFUL METAL-ON-METAL HIP PROSTHESIS AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT FURTHER NOTED JOINT CAPSULE FLUID UNDER PRESSURE, GRAYISH-BROWNISH FLUID, AND A PSEUDOCAPSULE DURING THE REVISION PROCEDURE. THE TAPER ADAPTER COULD NOT BE DISLODGED FROM THE STEM, AND HAD TO BE CUT WITH A MIDAS BURR TO EXTRACT IT. THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED, AND AN ACTIVE ARTICULATION LINER WAS IMPLANTED. IN ADDITION, OPERATIVE REPORT NOTED THAT THE PATIENT IS BILATERAL, AND UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 10 YEARS PRIOR TO THE INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6) 2000 DUE TO UNKNOWN REASONS. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447641 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 068800

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R