BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA HIGHLY CROSSLINKED ARTICULARSURFACE

    MDR report key: 3944061 · Received May 1, 2014

    Report

    Report Number
    1822565-2014-00549
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS LIKELY THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE. NO OTHER COMPLAINT OF THIS NATURE HAVE BEEN RECEIVED FOR THIS PRODUCT/LOT COMBINATION AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FROM THIS SURGEON. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND CONFORMING. DIMENSION MEASURE FOUND THE PART TO BE CONFORMING TO PRINT SPECS. VISUAL EXAMINATION IDENTIFIED THAT THE DOVETAIL FEATURE WAS COMPRESSED DOWN BOTH SIDES; INDICATING THAT THE ARTICULAR SURFACE WAS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. IT WAS ALSO NOTED THAT THERE IS GOUGING TO THE UNDERSIDE OF THE ARTICULAR SURFACE, LIKELY DUE TO REMOVAL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE DID NOT LOCK SECURELY ON TO THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262226 PERSONA HIGHLY CROSSLINKED ARTICULARSURFACE MBH ZIMMER, INC. 62304563

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR