BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 54MM

    MDR report key: 4210835 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08403
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    January 7, 2014
    Report Date
    October 10, 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
    NY, 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, ¿MATERIAL SENSITIVITY REACTIONS.¿ ¿POSTOPERATIVE BONE FRACTURE AND 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 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06694 AND -08402 / -08404).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2013. 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) 2013 REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO PAIN, DISCOMFORT, ELEVATED METAL ION LEVELS, AND ADVERSE REACTION TO METAL DEBRIS. OP REPORT NOTES THE PRESENCE OF LYSIS AROUND ACETABULAR COMPONENT, FLUID, AND CORROSION ON THE TAPER. THE CUP AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT MEDICAL RECORD ALSO INDICATES PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON THE LEFT HIP (B)(6) 2014 DUE TO PAIN, DISCOMFORT, ELEVATED METAL ION LEVELS, AND ADVERSE REACTION TO METAL DEBRIS. OP REPORT NOTES THE PRESENCE OF CORROSION AT HEAD AND NECK. THE CUP AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694013 M2A-38 CUP NON FLARED SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 317390

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R