BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WMT SLT TAPER COBALT-CHROME FEMORAL HEAD

    MDR report key: 6425542 · Received March 22, 2017

    Report

    Report Number
    3010536692-2017-00409
    Event Type
    Injury
    Date Received
    March 22, 2017
    Date of Event
    January 20, 2016
    Report Date
    March 6, 2017
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    PER MOHAMMED, R. AND P. CNUDDE, "SEVERE METALLOSIS OWING TO INTRAPROSTHETIC DISLOCATION IN A FAILED DUAL-MOBILITY CUP PRIMARY TOTAL HIP ARTHROPLASTY." J ARTHROPLASTY, 2012. 27(3): P. 493.E1-3: ALLEGEDLY, A (B)(6) YEAR OLD MALE WITH A CONTACT E FEMORAL STEM, PROFEMUR TI MODULAR NECK, 28MM COCR HEAD, AND A 52MM DUAL MOBILITY CUP OF ANOTHER MANUFACTURER (APOGEE, BIOTECHNI) UNDERWENT A REVISION DUE TO A LARGE CYST WITHIN THE ILIOPSOAS MUSCLE AND METALLOSIS. IN (B)(6) 2016 THERE WAS A NECK FRACTURE (REF. PHA0-1204). NO TRAUMA OCCUR. ADDITIONAL INFORMATION RECEIVED 06/10/2016, ALLEGEDLY, THERE WAS AN PROSTHETIC NECK BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206492 WMT SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention