BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HEAD STD NK

    MDR report key: 4560739 · Received March 2, 2015

    Report

    Report Number
    0001825034-2015-00790
    Event Type
    Injury
    Date Received
    March 2, 2015
    Date of Event
    March 11, 2013
    Report Date
    February 6, 2015
    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: "MATERIAL SENSITIVITY REACTIONS...IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-01584 / 01585 & 1825034-2015-00789 / 00790).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2004, AND A REVISION PROCEDURE PERFORMED ON (B)(6) 2013. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS THAT PATIENT HAD METAL-ON-METAL STAINING AND GRAYISH-BROWN FLUID WITH METALLOSIS. A REVIEW OF INVOICE HISTORY REVEALED THAT THE INITIAL RIGHT HIP ARTHROPLASTY PROCEDURE ON OCTOBER (B)(6) 2004. INVOICE HISTORY CONFIRMED THE DATE OF THE REVISION PROCEDURE AND THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE PROCEDURE ON (B)(6) 2004 WAS A CONVERSION FROM AN ENDOPROSTHESIS TO A TOTAL HIP WHERE A BIOMET ACETABULAR CUP AND MODULAR HEAD WERE IMPLANTED. PATIENT MEDICAL RECORDS FURTHER INDICATE THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2006 DUE TO OSTEOLYSIS, METALLOSIS AND LOOSENING OF THE FEMORAL STEM. REVISION OPERATIVE REPORT NOTES THE MODULAR HEAD AND FEMORAL STEM WERE REPLACED WITH BIOMET FEMORAL COMPONENTS AND CABLES WERE IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008 DUE TO LOOSENING OF THE FEMORAL STEM. REVISION OPERATIVE REPORT NOTES THE FEMORAL STEM AND MODULAR HEAD WERE REPLACED WITH COMPETITOR COMPONENTS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALS THE REVISION PROCEDURE PERFORMED ON (B)(6) 2013 WAS DUE TO LOOSENING OF THE ACETABULAR CUP, OSTEOLYSIS AND METALLOSIS. REVISION OPERATIVE REPORT NOTES METAL STAINING, GRAYISH-BROWN FLUID AND GREATER TROCHANTER NON-UNION WERE DISCOVERED. OPERATIVE REPORT FURTHER NOTES THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142036 M2A 38MM MOD HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 216370

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R