BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TAPER INSERT-6

    MDR report key: 3760524 · Received April 21, 2014

    Report

    Report Number
    0001825034-2014-03013
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    November 27, 2012
    Report Date
    August 12, 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
    IN, 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 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03012 /-03013 /-07504).

    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 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 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03012 / 03013).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, SORENESS AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT METALLOSIS, CORROSION, AND BROWN-GREY COLORED FLUID WERE ALLEGEDLY NOTED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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 BY PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT'S ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, SORENESS AND LOSS OF RANGE OF MOTION. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED THAT METALLOSIS, CORROSION, AND BROWN-GREY COLORED FLUID WERE ALLEGEDLY NOTED. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2012 DUE TO PAIN AND ELEVATED METAL ION LEVELS. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF BROWN-GREY FLUID, CORROSION AT THE TRUNNION, AND RETROVERTED CUP. THE MODULAR HEAD, TAPER ADAPTER AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A COMPETITORS CUP AND BIOMET HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241122 M2A-MAGNUM 42-50MM TAPER INSERT-6 PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 536410

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R