BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION T-HANDLE

    MDR report key: 2083062 · Received March 31, 2011

    Report

    Report Number
    1822565-2011-00810
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    1822565-2/24/2011-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE NEXGEN POSTERIOR REFERENCING INSTRUMENTS (PRI) INSTRUMENTS ARE NON-IMPLANTED, REUSABLE INSTRUMENTS THAT ARE USED DURING POSTERIOR APPROACH TOTAL KNEE ARTHROPLASTY. THE INSTRUMENTS UTILIZE ALUMINUM TITANIUM NITRIDE (ALTIN) BLACK COATING AS A COSMETIC MEANS TO DEPICT POINTS OF ATTACHMENT OR ADJUSTMENT ON THESE INSTRUMENTS. THE INSTRUMENT(S) NOTED ON THE COMPLAINT ARE INCLUDED IN A VOLUNTARY FIELD ACTION INITIATED ON (B)(6) 2011 FOR SPECIFIC LOTS WHICH HAVE THE POTENTIAL FOR EXHIBITING A BREAKDOWN OF THE ALUMINUM TITANIUM NITRIDE (ALTIN) BLACK COATING. (B)(4). BREAKDOWN OF THE ALTIN BLACK COATING WAS OBSERVED ON RETURNED INSTRUMENT(S). DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER 3 CYCLE STERILIZATION, RESIDUAL BLACK POWDER WAS FLAKING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION T-HANDLE LXH ZIMMER, INC. 61679835

    Patients

    Seq Age Sex Outcome Treatment
    1