BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE M-COR MODULAR HIP SYSTEMS

    MDR report key: 4616594 · Received January 23, 2015

    Report

    Report Number
    3007311878-2015-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    August 1, 2013
    Report Date
    January 16, 2014
    Manufacturer
    MIPRO US, INC
    Product Code
    LPH
    PMA / PMN Number
    053417
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    "IN OR ABOUT (B)(6) 2013 PLAINTIFF (...) SUSTAINED A COMPLETE FAILURE OF THE RIGHT PROSTHETIC M-COR MODULAR HIP SYSTEM DESIGNED, MANUFACTURED, SOLD, AND/ OR DISTRIBUTED BY DEFENDANTS, (...), WHEN IT FRACTURED AT THE NECK. THERE WAS NO FALL OR OTHER TRAUMATIC EVENT ASSOCIATED WITH THE AFOREMENTIONED RIGHT PROSTHESIS FAILURE. AS A CONSEQUENCE OF THE FOREGOING FAILURE OF THE M-COR MODULAR HIP SYSTEM DESIGNED, MANUFACTURED, SOLD, AND/ OR DISTRIBUTED BY DEFENDANTS, (...), PLAINTIFF (...) SUSTAINED SEVERE AND PERMANENT INJURIES; HE WAS REQUIRED TO UNDERGO MULTIPLE PERMANENT AND PAINFUL REVISION SURGERIES, INCLUDING THE REMOVAL AND RE-IMPLANTATION OF A REPLACEMENT PROSTHETIC: 1-825-143; 1547; SN: (B)(4); 1-211-256; 2616; 1-804-256; 2460; SN: (B)(4); 1-810-156; 1565; SN: (B)(4); 1-812-130; 2373 / 2; 1-812-135; 2374; 1-812-120; 2371.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53768 THE M-COR MODULAR HIP SYSTEMS HIP REPLACEMENT SYSTEM, LPH, LZO, KWY LPH MIPRO US, INC 1-820-099 2165

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| S