BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 3191816 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02255
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    April 29, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02228 & 1825034-2013-02253 / 02256).

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2006. SUBSEQUENTLY, PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION ON AN UNKNOWN DATE DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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 THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF ELEVATED LEVELS OF COBALT AND CHROMIUM, TISSUE AND BONE DESTRUCTION. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON NOVEMBER 2, 2006. SUBSEQUENTLY, PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION ON AN UNKNOWN DATE DUE TO INFECTION. THE CUP, HEAD, STEM, SLEEVE, AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. 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 THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF ELEVATED LEVELS OF COBALT AND CHROMIUM, TISSUE AND BONE DESTRUCTION. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE HIP ARTHROPLASTY PROCEDURE OCCURRED ON (B)(6) 2006. SUBSEQUENTLY, PATIENT UNDERWENT THE FIRST STAGE OF A TWO STAGE REVISION ON AN UNKNOWN DATE DUE TO INFECTION. THE CUP, HEAD, STEM, SLEEVE, AND TAPER INSERT WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED PATIENT WAS REIMPLANTED ON (B)(6) 2010. CEMENT SPACER MOLDS WERE REMOVED AD COMPETITOR PRODUCT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289721 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 969060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R