BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 4251119 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08548
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    December 14, 2012
    Report Date
    January 8, 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
    UT, 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: ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES,¿ "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS," AND ¿POSTOPERATIVE PAIN." 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08547 / 08548).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION THAT WAS REPORTED IN ERROR ON A PREVIOUS MEDWATCH. REVISION SURGERY WAS (B)(6) 2012 AND NOT (B)(6) 2012 AS WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN AND LIMITED MOBILITY. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. 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 REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN AND LIMITED MOBILITY. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, IT INDICATES THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED METAL ION LEVELS, PAIN AND LIMITED MOBILITY. THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE; HOWEVER, IT INDICATES THAT THE REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEAL THE (B)(6) 2012 REVISION WAS DUE TO PAIN AND A LOOSE ACETABULAR COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED METAL WEAR ON SOFT TISSUES, A GRAYISH BLACK APPEARANCE TO SOFT TISSUES, NO BONY INGROWTH ON THE CUP AND SCAR TISSUE. THE MODULAR HEAD, ACETABULAR CUP, AND TAPER ADAPTER WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION IN PATIENT MEDICAL RECORDS REVEAL PATIENT'S JOINT FLUID WAS TESTED ON (B)(6) 2012 AND PATIENT'S BLOOD WAS TESTED ON (B)(6) 2012..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737357 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 848360

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R