BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX56MM

    MDR report key: 3972651 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06698
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    August 2, 2006
    Report Date
    July 14, 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.¿ 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." AND ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE (REFERENCE 1825034-2012-01613, 1825034-2014-02454/ -02455, -02457, -06679, & -06698).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT M2A HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, IT IS ALLEGED THAT PATIENT WAS REVISED ON (B)(6) 2006, FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, ELEVATED METAL ION LEVELS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND LACK OF MOBILITY. LEGAL DOCUMENT FURTHER ALLEGES THE PRESENCE OF METALLOSIS WEAR DEBRIS AND AN INFLAMMATORY PSEUDOTUMOR DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORD INDICATES THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY ON AN UNREPORTED DATE IN OR AROUND 2000. REVISION OPERATIVE (OP) NOTES DATED (B)(6) 2004 REPORT PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. OP REPORT NOTES DEBRIS IN THE JOINT, JOINT FLUID, CUP INSTABILITY WITH AN INTACT LINER, PELVIC DEFICIENCY, AND CYSTIC DEFORMATION ON THE LEFT HEMIPELVIS. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OP NOTES DATED (B)(6) 2006 REPORTS THE PATIENT UNDERWENT A SECOND LEFT HIP REVISION DUE TO PAIN AND A LOOSE CUP. REVISION OP REPORT NOTES NO BONY INGROWTH WAS OBSERVED. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OP NOTES DATED (B)(6) 2010 REPORTS THE PATIENT UNDERWENT A THIRD LEFT HIP REVISION DUE TO PAIN. REVISION OP REPORT NOTES METALLOSIS WEAR DEBRIS, INFLAMMATORY TYPE OF PSEUDOTUMOR REACTION, LOOSE CUP, AND MEDIAL ACETABULAR BONE DEFECT. THE MODULAR HEAD WAS REMOVED AND REPLACED. THE CUP WAS REMOVED AND REPLACED WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451231 M2A 1 PC SHELL 38MMX56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 646750

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R