BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 3912506 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00616
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS EVIDENT THAT THE HOLE THAT CONTAINED THE COMPONENTS HAD GONE THROUGH THE SWAGING PROCESS. THE SWAGING PROCESS IS VALIDATED PER THE SUPPLIER TO PRODUCE A CONFORMING SWAGED HOLE DIAMETER. THE CAUSE OF THE MISSING COMPONENT IS UNK. EVAL: VISUAL EXAMINATION IDENTIFIED MISSING SUB-COMPONENTS FROM THE SWAGED HOLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL IS MISSING A BALL BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287885 PERSONA TIBAL ARTICULAR SURFACE PROVISIONAL JWH ZIMMER, INC. 62072563

    Patients

    Seq Age Sex Outcome Treatment
    1