BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50 TAPER INSERT STD

    MDR report key: 2801028 · Received October 23, 2012

    Report

    Report Number
    0001825034-2012-02099
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." AND "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 3 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02097 / 02104).

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY," "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES," ¿INADEQUATE RANGE OF MOTION,¿ AND ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿

    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.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2007 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6), 2012. PATIENT ALLEGATIONS INCLUDE LOOSENING OF METAL COMPONENTS, NECROSIS OF TISSUE AND METAL IN BLOODSTREAM. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THE REVISION PROCEDURE DATE. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING ADDITIONAL REVISION PROCEDURES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION FROM THE PATIENT'S LEGAL COUNSEL REVEALS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION AND MOBILITY, AND DIFFICULTY IN WALKING.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012. PATIENT ALLEGATIONS INCLUDE LOOSENING OF METAL COMPONENTS, NECROSIS OF TISSUE AND METAL IN BLOODSTREAM. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THE REVISION PROCEDURE DATE. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP. ADDITIONAL INFORMATION FROM THE PATIENT'S LEGAL COUNSEL REVEALS PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION AND MOBILITY, AND DIFFICULTY IN WALKING. 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 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAIN AND ILIOPSOAS TENDONITIS. REVISION OP REPORT NOTES THE PRESENCE OF NORMAL-APPEARING FLUID AND FIRM, RIGID, THICK FIBROTIC TISSUE ENCASING AND TRAPPING THE ILIOPSOAS TENDON. IN ADDITION, OP REPORT NOTES THE HEAD HAD FORMED A COLD WELD ON THE MORSE TAPER AND MODULAR HEAD WOULD NOT DISENGAGE FROM THE TAPER. THE CUP, HEAD, STEM, AND TAPER INSERT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2012. PATIENT ALLEGATIONS INCLUDE LOOSENING OF METAL COMPONENTS, NECROSIS OF TISSUE AND METAL IN BLOODSTREAM. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATES AND THE REVISION PROCEDURE DATE. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING ADDITIONAL 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
    1 M2A-MAGNUM 42-50 TAPER INSERT STD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 615160

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R