BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUK ARTICULAR SURFACE PROVISIONAL

    MDR report key: 2062891 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00670
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 22, 2009
    Report Date
    January 4, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED, THE ARTICULAR SURFACE PROVISIONAL IS FRACTURED ALONG ONE OF THE CHANNELS ON ITS UNDERSIDE. THE PART HAS A POTENTIAL FIELD AGE OF NEARLY 5 YEARS. A RADIUS WAS ADDED TO THE FEATURE IN 2008 IN AN ATTEMPT TO REDUCE THE OCCURRENCE OF THIS TYPE OF FAILURE. EVALUATION: THE RETURNED DEVICE WAS DIMENSIONALLY VERIFIED TO MEET PRINT SPECIFICATION. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUK ARTICULAR SURFACE PROVISIONAL JWH ZIMMER, INC. 60250799

    Patients

    Seq Age Sex Outcome Treatment
    1