BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM TRISPIKE CUP 52ODX46ID

    MDR report key: 3852287 · Received June 5, 2014

    Report

    Report Number
    0001825034-2014-05301
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 23, 2013
    Report Date
    May 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062995
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE MATERIAL ANALYSIS, IT WAS NOTED THE COMPONENT SHOWED EVIDENCE OF SCRATCHES, DEFORMATION AND POSSIBLE METALLIC TRANSFER AND SUBLUXATION. IT WAS ALSO NOTED THE COMPONENT WAS MISSING POROUS COATING NEAR THE INFERIOR RIM.

    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: MATERIAL SENSITIVITY REACTIONS. 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 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02965 AND 2014-05301).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE PATIENT¿S (B)(6) 2014 REVISION WAS DUE TO METALLOSIS. THE PATIENT¿S OPERATIVE REPORT NOTED SWOLLEN MUSCULAR TISSUE, ABDUCTOR DESTRUCTION AND A ELEVATED NEUTROPHIL COUNT. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013 A MRI WAS PERFORMED. FURTHER INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS NOTED THAT ON (B)(6) 2013 PATIENT¿S BLOOD WAS TESTED. 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
    328798 MAGNUM TRISPIKE CUP 52ODX46ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 008470

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R