BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 3790255 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03506
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 7, 2014
    Report Date
    July 30, 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
    FL, 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: 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 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03505/03508).

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " UNDESIRABLE SHORTENING OF LIMB. "

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FURTHER ALLEGED NECROTIC TISSUE, OSTEOLYSIS, EFFUSION, BLACK STAINED TISSUE, METAL DEBRIS, AND BONE DAMAGE WERE NOTED DURING THE REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY AND WHICH COMPONENTS 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

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON V 2013 DUE TO PATIENT ALLEGATIONS OF PAIN AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FURTHER ALLEGED NECROTIC TISSUE, OSTEOLYSIS, EFFUSION, BLACK STAINED TISSUE, METAL DEBRIS, AND BONE DAMAGE WERE NOTED DURING THE REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, AN INVOICE COULD NOT BE LOCATED TO CONFIRM THE REVISION SURGERY AND WHICH COMPONENTS 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) 2013 DUE TO PAIN AND A LEG LENGTH DISCREPANCY. REVISION OPERATIVE REPORT NOTED THE PRESENCE OF NECROTIC TISSUE, EFFUSION, BLACK STAINED TISSUE, FLUID, AND THINNING OF THE BONES DUE TO OSTEOLYSIS. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266380 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 563370

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R