BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 50ODX44ID

    MDR report key: 3894206 · Received June 25, 2014

    Report

    Report Number
    0001825034-2014-05770
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    March 16, 2011
    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
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    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

    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 THESE TYPES OF EVENTS CAN OCCUR UNDER POSSIBLE ADVERSE EFFECTS: 1. MATERIAL SENSITIVITY REACTIONS. 6. INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS. 14. INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN. 15. ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05767 / 05770).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2011 AND RIGHT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2011. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORT PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, SORENESS, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. 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 THE REASON FOR THE LEFT HIP REVISION WAS A LOOSE ACETABULAR COMPONENT AND ACETABULAR FRACTURE. OPERATIVE REPORT FURTHER NOTED A LARGE HIP EFFUSION AND A T-SHAPED ACETABULAR FRACTURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REPLACED AND AN ACTIVE ARTICULATION POLYETHYLENE ACETABULAR LINER WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE REPORT NOTED THE REASON FOR THE RIGHT HIP REVISION WAS PAIN. OPERATIVE REPORT FURTHER NOTED PATIENT HAD PREVIOUSLY UNDERGONE AN ASPIRATION WHERE GRAYISH-TYPE FLUID WAS REMOVED, BUT NO SIGNS OF INFECTION WERE PRESENT. DURING THE REVISION, HEMORRHAGIC FLUID WAS ENCOUNTERED. THE MODULAR HEAD AND ACETABULAR CUP WERE REPLACED AND AN ACTIVE ARTICULATION POLYETHYLENE ACETABULAR LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTS THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2009 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEFT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2011 AND RIGHT HIP REVISION PROCEDURE OCCURRED ON (B)(6) 2011. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORT PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, DYSFUNCTION, SORENESS, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. 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
    370276 M2A-MAGNUM PF CUP 50ODX44ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 493170

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R