BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM TAPER ADAPTER 42-50MM STANDARD

    MDR report key: 2760087 · Received September 26, 2012

    Report

    Report Number
    0001825034-2012-01725
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    March 16, 2011
    Report Date
    August 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01724 / 01726).

    Additional Manufacturer Narrative · 1

    REVIEW OF INVOICE HISTORY CONFIRMED THAT A CEMENT SPACER MOLD AND CABLES WERE IMPLANTED DURING THE REVISION PROCEDURE, WHICH INDICATES THAT A BONE FRACTURE OCCURRED AND THAT THE JOINT WAS INFECTED. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." AND "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 2 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01724 / 01726 & 1825034-2012-02451).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE ADDITIONAL INFORMATION RECEIVED IN THE BLOOD TESTS AND MEDICAL RECORDS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." 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 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01724 / 01726 & 02451).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE HEAD AND STEM WERE REMOVED AND REPLACED WITH SPACER MOLDS AND IMPLANTATION OF CABLES DURING THE REVISION THAT OCCURRED ON (B)(6) 2011. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF ELEVATED COCR LEVELS AND TISSUE/BONE DESTRUCTION. A REVIEW OF INVOICE HISTORY CONFIRMED THE HEAD AND STEM WERE REMOVED AND REPLACED WITH SPACER MOLDS AND IMPLANTATION OF CABLES DURING THE REVISION THAT OCCURRED ON (B)(6), 2011. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2011 WAS DUE TO PAIN, ELEVATED METAL ION LEVELS, ACETABULAR CUP LOOSENING, AND INFECTION. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, FEMORAL STEM, TAPER ADAPTER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM TAPER ADAPTER 42-50MM STANDARD PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 756740

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R