BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NRG KNEE P/S NRG BEARING INSERT SIZE

    MDR report key: 2941860 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00548
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 18, 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

    UPDATED IMPLANT DATE BASED ON ADDITIONAL INFORMATION. THE PATIENT IS (B)(6). AN EVENT REGARDING WEAR INVOLVING A NRG KNEE P/S NRG BEARING INSERT SIZE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT ((B)(4)). THE REPORT INDICATED: "SYMMETRICAL PATTERNS OF BURNISHING, SURFACE DEFORMATION AND THIRD BODY INDENTATIONS WERE EVIDENT ON THE ARTICULATING SURFACE." "NO REMAINING THIRD BODY DEBRIS WAS FOUND ON THE ARTICULATING SURFACE." "THERE WAS NO EVIDENCE OF WHITE FLAKE BAND ON THE INSERT THAT COULD INDICATE SIGNS OF OXIDATION." "DAMAGE TO THE DISTAL SURFACE INCLUDED SURFACE TEXTURES FROM THE TIBIAL TRAY OCCURRING DURING IN-VIVO SERVICE. EXPLANTATION RELATED DAMAGES INCLUDING NICKS AND CUTS WERE EVIDENT ON THE DISTAL AND ANTERIOR SURFACES. THE INSERT MATERIAL WAS DISCOLORED YELLOW." "THERE IS ABRASIVE WEAR DAMAGE ON ONE SIDE OF THE POST OF THE PS INSERT." A MATERIAL ANALYSIS WAS ALSO PERFORMED. THE REPORT CONCLUDED THAT THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE RETURNED ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) TIBIAL INSERT. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "X-RAYS INCLUDES A SERIES LABELED OFF THE FILMS 'POST-IMPLANTATION 2008,' WHICH INCLUDES AN AP AND LATERAL OF A CEMENTED RIGHT TOTAL KNEE ARTHROPLASTY IN NOMINAL POSITION WITH NO PATHOLOGY. A SECOND SERIES LABELED OFF THE FILMS 'PRE-REVISION 2012' IS AN AP AND LATERAL OF THE RIGHT KNEE, WHICH IS ESSENTIALLY UNCHANGED." THE CLINICIAN'S REVIEW OF THE X-RAYS DID NOT SUGGEST ANY EVIDENCE OF A OF FAULTY PROSTHETIC DESIGN OR MANUFACTURING ISSUE ASSOCIATED WITH THE DEVICE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT CONCLUSIONS: WEAR ANALYSIS OF THE RETURNED INSERT INDICATES THAT THE MEASURED LINEAR PENETRATION WEAR RATES OF THE ARTICULATING SURFACES WERE LESS THAN WEAR RATES REPORTED IN PREVIOUS CLINICAL STUDIES. FURTHER TO THIS THERE WAS NO EVIDENCE FROM THE CLINICIAN'S REVIEW OF THE X-RAYS TO SUGGEST A DEVICE RELATED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED DUE TO THE ARTHRITIC SYMPTOM 4 YEARS AND 6 MONTHS AFTER THE PRIMARY OP ON (B)(6) 2008. THE SURGEON REPLACED THE INSERT ON (B)(6) 2012 DUE TO OA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED DUE TO THE ARTHRITIC SYMPTOM 4 YEARS AND 6 MONTHS AFTER THE PRIMARY OP ON (B)(6) 2008. THE SURGEON REPLACED THE INSERT ON (B)(6) 2012 DUE TO OA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46943 NRG KNEE P/S NRG BEARING INSERT SIZE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 26661001

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R