BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3813498 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04133
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    January 3, 2012
    Report Date
    July 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." 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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04133 / 04134).

    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. THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04133 / 04134 AND -06294 / -06295).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED COBALT AND CHROMIUM LEVELS, TISSUE AND BONE DESTRUCTION, PAIN, ACETABULAR CUP LOOSENING, METALLIC DEBRIS AND STAINING. 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 PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF ELEVATED COBALT AND CHROMIUM LEVELS, TISSUE AND BONE DESTRUCTION, PAIN, ACETABULAR CUP LOOSENING, METALLIC DEBRIS, AND STAINING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO A LOOSE ACETABULAR COMPONENT. REVISION OP REPORT NOTES THE PRESENCE OF MILKY GRAY-TINGED FLUID CONSISTENT WITH METALLOSIS DEBRIS, METAL PARTICLES INSIDE THE JOINT, METALLIC MATERIAL INSIDE THE BONE, AND METALLIC STAINING OF THE BONE. THE CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION FROM PATIENT MEDICAL RECORDS REPORTS PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2008. THERE HAS BEEN NO REVISION PROCEDURE REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290531 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 344910

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R