BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 3945491 · Received July 21, 2014

    Report

    Report Number
    0001825034-2014-06302
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    April 25, 2013
    Report Date
    July 11, 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
    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, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ 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 NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04678 AND -06302).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. A REVISION PROCEDURE ON (B)(6) 2012, WAS CONDUCTED DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, AND ELEVATED METAL ION LEVELS. 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) 2012 REPORTS: PATIENT WAS REVISED DUE TO METAL-ON-METAL DISEASE AND ELEVATED METAL ION LEVELS OF COBALT AND CHROMIUM. REVISION OP REPORT NOTES IRRITATION AND DISCOLORATION OF THE SYNOVIAL FLUID AND SCAR TISSUE SURROUNDING THE JOINT. THE MODULAR HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OP NOTES DATED (B)(6) 2013 REPORTS: PATIENT UNDERWENT A SECOND REVISION ON THE LEFT HIP DUE TO PAIN AND FIBROUS UNION OF THE CUP. REVISION OP REPORT NOTES THE PRESENCE OF TWO ANTERIOR OSTEOPHYTES, WHICH HAD GROWN OVER THE EDGE OF THE CUP AND NO BONY INGROWTH. THE CUP AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424596 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 590320

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R