BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD+6MM NK NO SKRT

    MDR report key: 3841486 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05071
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    August 8, 2007
    Report Date
    May 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 10 STATES, ¿FRETTING AND CREVICE CORROSION MAY OCCUR AT INTERFACES BETWEEN COMPONENTS.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01610, -01612, -05070 / -05072).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2005 AND A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP DUE TO PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES DATED (B)(6) 2007 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO LOOSENING AND PATIENT ALLEGATIONS OF PAIN, FLEXOR WEAKNESS, AND WALKING INTOLERANCE. REVISION OP REPORT NOTES FLUID, FIBERS, BONE LOSS, AND LOOSENING OF FEMORAL AND ACETABULAR COMPONENTS. THE HEAD, CUP, AND STEM WERE REMOVED AND REPLACED. PATIENT OP NOTES DATED (B)(6) 2013 REPORTS PATIENT WAS REVISED ON THE RIGHT HIP DUE TO WEAR OF THE ARTICULAR SURFACE AND ELEVATED METAL ION LEVELS. RIGHT REVISION OP REPORT NOTES THE PRESENCE OF METAL STAINING OF THE SYNOVIUM, FRAYING OF THE FEMORAL NECK TAPER, AND VERTICAL POSITIONING OF THE ACETABULAR CUP. THE HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318297 M2A 38MM MODULAR HEAD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 077990

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R