BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN XLPE PS INSERT SZ 5-6 9MM

    MDR report key: 4190248 · Received October 21, 2014

    Report

    Report Number
    1020279-2014-00654
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS YELLOWING OF THE INSERT. A REVIEW OF THE COMPLAINT HISTORY SHOWS NO PRIOR COMPLAINTS FOR THE LISTED LOT. A LAB ANALYSIS WAS COMPLETED. A MICROTOME WAS USED TO PRODUCE A THIN FILM (190 ¿M THICK) THROUGH THE THICKNESS OF THE IMPLANT IN THE YELLOW REGION. MEASUREMENT OF THE OXIDATION IN THE UHMWPE TIBIAL INSERT WAS CONDUCTED, THE PRESENCE OF A KETONE PEAK AT 1718 CM-1 WAS UTILIZED AS AN INDICATOR OF OXIDATION. IN ADDITION, IT IS KNOWN THAT UHMWPE MATERIAL WITHIN THE BODY CAN ABSORB ESTERIFIED FATTY ACIDS (EFAS) FROM THE PHYSIOLOGICAL ENVIRONMENT, WHICH CAN PRODUCE A YELLOW COLOR IN THE UHMWPE MATERIAL SIMILAR TO OXIDATION. THE PRESENCE OF AN ESTER PEAK AT ABOUT 1738 CM-1 WAS UTILIZED AS AN INDICATOR OF EFA ABSORPTION. THERE WERE ESTER PEAKS AT ABOUT 1738 CM-1 DUE TO ABSORBED EFAS NEAR BOTH THE DISTAL AND PROXIMAL SURFACES. NO KETONE PEAKS WERE OBSERVED AT ABOUT 1718 CM-1, WHICH SUGGESTS THAT OXIDATION HAD NOT OCCURRED. IT SHOULD BE NOTED THAT THE RELATIVELY LARGE ESTER PEAKS HAVE SHOULDERS THAT OVERLAP THE KETONE REGION (1718 CM-1). THEREFORE, IT IS POSSIBLE THAT A SMALL AMOUNT OF OXIDATION HAD OCCURRED IN THIS IMPLANT BUT THAT IT IS OBSCURED BY THESE ESTER PEAKS. NONETHELESS, THIS DATA SUGGESTS THAT LITTLE TO NO OXIDATION HAD OCCURRED AND THAT THE YELLOW COLOR IS DUE TO ESTERIFIED FATTY ACIDS THAT WERE ABSORBED FROM THE PHYSIOLOGICAL ENVIRONMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    KNEE REVISION WAS REPORTED DUE TO PATELLA PAIN. PATELLA WAS NOT RESURFACED AT THE INDEX PROCEDURE. IT WAS RESURFACED AND INSERT EXCHANGED DURING THIS REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668520 LGN XLPE PS INSERT SZ 5-6 9MM ARTICULAR INSERTS JWH SMITH & NEPHEW, INC. 11BM05157

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R