BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISODUR PROSTHESIS HEAD 12/14 32MM L

    MDR report key: 4047636 · Received August 7, 2014

    Report

    Report Number
    2916714-2014-00623
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    August 6, 2014
    Manufacturer
    AESCULAP AG&CO KG
    Product Code
    LPH
    PMA / PMN Number
    K040191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K): K081973. US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVALUATION: FAILURE OCCURRED IN BATCHES MANUFACTURED BETWEEN FEBRUARY AND MAY 2008. PACKAGING WAS CHANGED FROM (B)(4). NO FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CLIENT COMPLAINED: PACKAGING FOIL STICKS TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466336 ISODUR PROSTHESIS HEAD 12/14 32MM L HIP ENDOPROSTHETICS LPH AESCULAP AG&CO KG NK531K 51486700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other