BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA STANDARD

    MDR report key: 1549551 · Received December 1, 2009

    Report

    Report Number
    2648920-2009-00063
    Event Type
    Other
    Date Received
    December 1, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEXGEN 32 MM ALL-POLY PATELLA WAS IMPLANTED WITH A SIZE G, LPS-FLEX FEMORAL COMPONENT AND THE PATELLA WAS NOT "INSET". IT IS INDICATED IN THE PACKAGE INSERT TO INSET THE PATELLA WHEN THIS SIZE COMBINATION IS USED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ITEM WAS IMPLANTED ON (B) (6) 2009. AFTER CHECKING LITERATURE, IT WAS DISCOVERED THAT THIS COMBINATION IS NOT OKAY. AN OFFSET PATELLA WAS IMPLANTED. THE INSERT FOR G FEMUR, WHICH THE LITERATURE SAYS IT NEEDS TO BE AN INSET AND NOT AN OFFSET PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ALL POLY PATELLA STANDARD KNEE PROSTHESIS HTG ZIMMER MANUFACTURING B.V. NA 61321767

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR