BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD+6MM NK NO SKRT

    MDR report key: 3142900 · Received June 3, 2013

    Report

    Report Number
    0001825034-2013-01776
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    August 22, 2012
    Report Date
    March 20, 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
    TX, 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." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." AND "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01776 / 01777). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION FROM PATIENT MEDICAL RECORDS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE FOLLOWING SECTION WAS UPDATED AS A RESULT: EVENT DESCRIPTION.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, AND ELEVATED METAL IONS. ADDITIONAL ALLEGATIONS INDICATE THE PRESENCE OF A MILKY FLUID AND METALLOSIS WERE NOTED DURING THE REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE NOTES INDICATE THE PRESENCE OF METALLOSIS IN THE BURSA OVER THE ABDUCTORS WITH MARKED MILKY FLUID. DAMAGE TO THE ABDUCTORS WAS NOTED AND PSEUDOCAPSULE WAS EXCISED. THERE WAS CORROSION OF THE NECK-HEAD JUNCTION. OPERATIVE NOTES FURTHER INDICATED THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED WITH COMPETITOR ACETABULAR COMPONENTS AND A BIOMET HEAD. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTS THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, AND ELEVATED METAL IONS. ADDITIONAL ALLEGATIONS INDICATE THE PRESENCE OF A MILKY FLUID AND METALLOSIS WERE NOTED DURING THE REVISION PROCEDURE. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES. 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
    243183 M2A 38MM MODULAR HEAD+6MM NK NO SKRT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 049790

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R