BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG KNEE P/S NRG BEARING INSERT SIZE

    MDR report key: 3233162 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02357
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR), THE REPORT INDICATED: AN OVERALL IMAGE OF THE ARTICULATING SURFACE OF THE TIBIAL INSERT IS SHOWN IN FIGURE 1. THE DEVICE WAS EVALUATED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 50X. BURNISHING SCRATCHING AND THIRD BODY INDENTATIONS WERE DAMAGE MODES EVIDENT ON AREAS OF THE ARTICULATING SURFACE. A DETAILED IMAGE OF THE REPRESENTATIVE ARTICULATING SURFACE CONDITION IS SHOWN IN FIGURE 2. A HOLE USED TO AID IN THE EXPLANTATION OF THE DEVICE WAS OBSERVED ON THE CENTRAL EMINENCE". "IMAGES OF THE TIBIAL POST ARE SHOWN IN FIGURES 3-6. LOCALIZED ABRASION WAS OBSERVED PRIMARILY ON ONE SIDE OF THE TIBIAL POST. THIS DAMAGE LIKELY OCCURRED DUE TO CONTACT WITH BONE OR BONE CEMENT INSIDE THE BOX OF THE FEMORAL COMPONENT. THE DISTAL SURFACE OF THE TIBIAL INSERT IS SHOWN IN FIGURE 7. DAMAGE TO THE DISTAL SURFACE INCLUDED IMPRESSIONS OF THE SURFACE TEXTURES FROM THE TIBIAL TRAY OCCURRING DURING IN-VIVO SERVICE." THE MAR REPORT CONCLUDED " IN-VIVO SERVICE RELATED DAMAGES TO THE ARTICULATING SURFACE OF THE INSERT INCLUDED BURNISHING, SCRATCHING AND THIRD BODY INDENTATIONS. THESE ARE COMMONLY IDENTIFIED DAMAGE MODES ON UHMWPE TIBIAL INSERTS. LOCALIZED ABRASION WAS ALSO OBSERVED ON THE TIBIAL POST. THE AVERAGE LINEAR PENETRATION WEAR RATE ON THE ARTICULATING SURFACES WAS LESS THAN THE AVERAGE WEAR RATE REPORTED IN PREVIOUS CLINICAL STUDIES. THE MAXIMUM OXIDATION INDEXES OI MEASURED ON THE ARTICULATING SURFACE, THE POSTERIOR EDGE AND THE BACKSIDE SURFACE WERE CONSISTENT WITH MAXIMUM OI RANGES REPORTED IN PREVIOUS CLINICAL STUDIES. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE RETURNED ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) TIBIAL INSERT" DEVICE HISTORY REVIEW INDICATED ALL DEVICES FOR BOTH REPORTED LOTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED FOR BOTH LOTS REPORTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. A MATERIAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE AND THE AVERAGE LINEAR PENETRATION WEAR RATE ON THE ARTICULATING SURFACES WAS LESS THAN THE AVERAGE WEAR RATE REPORTED IN PREVIOUS CLINICAL STUDIES. FURTHER TO THIS ALL OXIDATION DATA FOR THIS RETURNED COMPONENT FELL WITHIN THE CLINICALLY OBSERVED MAXIMUM OXIDATION RANGES. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, X-RAYS AND PROGRESS NOTES ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OSTEOLYSIS OCCURRED BY THE WEAR OF THE INSERT AND THE TIBIAL COMPONENT LOOSENED. THESE IMPLANTS WERE IMPLANTED ON (B)(6) 2007. THE TIBIAL COMPONENT SANK DUE TO THE MEDIAL BONE DEFECT. THE PATIENT CAME TO THE HOSPITAL DUE TO THE INSTABILITY OF THE KNEE AND PAIN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. TS TYPE IMPLANT (BIOMET PRODUCT)WAS USED FOR THE REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OSTEOLYSIS OCCURRED BY THE WEAR OF THE INSERT AND THE TIBIAL COMPONENT LOOSENED. THESE IMPLANTS WERE IMPLANTED ON (B)(6) 2007. THE TIBIAL COMPONENT SANK DUE TO THE MEDIAL BONE DEFECT. THE PATIENT CAME TO THE HOSPITAL DUE TO THE INSTABILITY OF THE KNEE AND PAIN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. TS TYPE IMPLANT (BIOMET PRODUCT)WAS USED FOR THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333690 NRG KNEE P/S NRG BEARING INSERT SIZE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R