BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 5904834 · Received August 25, 2016

    Report

    Report Number
    0001825034-2016-03231
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    May 12, 2014
    Report Date
    August 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ 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 3 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03231 / 03233). DEVICE NOT RETURNED BY ATTORNEY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - M2A MAGNUM ACETABTULAR CUP CATALOG#: US157856 LOT#: 580400, TAPERLOC FEMORAL STEM CATALOG#: 11-103201 LOT#: 069650, M2A MAGNUM TAPER ADAPTER CATALOG#: 139252 LOT#: 980230.

    Additional Manufacturer Narrative · 1

    THE INITIAL NOTIFICATION DATE OF THE REPORTED EVENT HAS BEEN CORRECTED TO BE (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO ALLEGED METAL ON METAL LOCAL TISSUE REACTION AND LOOSE ACETABULAR COMPONENT. THE MODULAR HEAD AND ACETABULAR SHELL WERE REMOVED AND REPLACED. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO ALLEGED METAL ON METAL LOCAL TISSUE REACTION, LOOSE ACETABULAR COMPONENT AND ELEVATED METAL ION LEVELS. THE MODULAR HEAD AND ACETABULAR SHELL WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN, METAL ON METAL LOCAL TISSUE REACTION AND LOOSE ACETABULAR COMPONENT. THE MODULAR HEAD AND ACETABULAR SHELL WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556147 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 233890

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R