BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCIA L PLASMAPORE UCAP 8/10 SIZE 11MM

    MDR report key: 3908039 · Received March 6, 2014

    Report

    Report Number
    3005673311-2014-00014
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Report Date
    February 28, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LWJ
    PMA / PMN Number
    K601344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K081973. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: WAITING FOR PRODUCT RETURN FROM USER FACILITY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). BREAKAGE OF THE NECK OF HIP PROSTHESIS (RIGHT SIDE). REVISION INCLUDED CHANGE OF TOTAL HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136820 EXCIA L PLASMAPORE UCAP 8/10 SIZE 11MM LWJ AESCULAP AG AND CO. KG NC431T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other