BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 54ODX48ID

    MDR report key: 3890837 · Received June 24, 2014

    Report

    Report Number
    0001825034-2014-05712
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 17, 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
    MN, 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." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-06190 AND 2014-05712).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2011. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO A PSEUDOTUMOR. THE MODULAR HEAD TAPER ADAPTOR AND ACETABULAR CUP WERE REMOVED AND REPLACED WITH A BIOMET HEAD AND COMPETITOR CUP AND LINER. ADDITIONAL INFORMATION FROM LEGAL COUNSEL FOR THE PATIENT REPORTS PATIENT ALLEGATIONS OF PAIN, TROCHANTERIC BURSITIS, TENDERNESS, SWELLING, INFLAMMATION, DISFIGUREMENT, DISABILITY, ELEVATED CHROMIUM AND COBALT AND METALLOSIS. LEGAL COUNSEL FURTHER REPORTS THAT FLUID AND INFLAMED TISSUE WERE NOTED DURING THE REVISION SURGERY ON (B)(6) 2013. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE LEFT HIP REVISION PROCEDURE PERFORMED ON (B)(6) 2013 WAS DUE TO FLUID COLLECTION AND POSSIBLE METAL-METAL REACTION. THE OPERATIVE REPORT NOTED SOFT TISSUE REACTION DUE TO METAL DEBRIS; YELLOW FLUID WITH FLOCCULENT MATERIAL; A CYST; AND TISSUE THAT HAD TYPICAL FINDINGS OF ALVAL. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013 PATIENT¿S BLOOD WAS TESTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368161 M2A-MAGNUM PF CUP 54ODX48ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 071330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R