BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA

    MDR report key: 1150085 · Received August 29, 2008

    Report

    Report Number
    1822565-2008-00560
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    February 9, 2006
    Report Date
    July 30, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT RETURNED FOR EVALUATION. ALSO X-RAYS ARE NOT AVAILABLE FOR REVIEW. THE CAUSE OF THE PATELLA CLUNK COULD NOT BE DETERMINED, DUE TO INSUFFICIENT INFORMATION. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE, AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. THE PATIENT WAS DIAGNOSED WITH PATELLA CLUNK, WHICH RESULTED IN TREATED OF SYNOVECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA KNEE PROSTHESIS HTG ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR