BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM

    MDR report key: 3901592 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05776
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    November 7, 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
    CO, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." 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.

    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: UNDER POSSIBLE ADVERSE EFFECTS: "UNDESIRABLE SHORTENING OF LIMB." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05776 AND 08718).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, METALLOSIS, AND METAL DEBRIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED AND THE ACETABULAR CUP REMAINED IMPLANTED. 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

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, METALLOSIS, AND METAL DEBRIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED AND THE ACETABULAR CUP REMAINED IMPLANTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, METALLOSIS, AND METAL DEBRIS. REVIEW OF INVOICE HISTORY CONFIRMS THE MODULAR HEAD WAS REMOVED AND REPLACED AND THE ACETABULAR CUP REMAINED IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATE THE (B)(6) 2014 REVISION WAS DUE TO PAIN, SYNOVITIS, AND LEG LENGTH DISCREPANCY. THE PATIENT'S OPERATIVE REPORT NOTED METALLOSIS, SYNOVITIS, FIBRINOUS DEBRIS, AND TRUNNIONOSIS. THE TAPER ADAPTER WAS REMOVED AND REPLACED, AND THE STEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379878 M2A-MAGNUM MOD HD SZ 42MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 805400

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R