BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 1864852 · Received September 28, 2010

    Report

    Report Number
    2648920-2010-00050
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Removal / Correction Number
    2648920-08/27/2010-002R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS SUSPECTED THAT THE CAUSE OF THIS MALFUNCTION IS RELATED TO AN ASSEMBLY ERROR DURING MANUFACTURING. AS A RESULT, THIS LOT AS WELL AS ANOTHER LOT WERE RECALLED. REFERENCE REMOVAL REPORT (B)(4) FOR ADDITIONAL INFO. EVAL: AS RETURNED, ONE PLUG WAS MISSING AND THE OTHER THREE PLUGS WERE NOT ASSEMBLED TO THE TIBIA PLATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON OPENING THE INSIDE STERILE BOX, THE IMPLANT WAS REMOVED AND THE SURGICAL TECH NOTICED THREE WHITE PLUGS HAD FALLEN OUT AND ONE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT PRECOAT KNEE PROSTHESIS JWH ZIMMER 61313261

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR