BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE

    MDR report key: 5879894 · Received August 16, 2016

    Report

    Report Number
    0001822565-2016-02855
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 15, 2016
    Report Date
    January 25, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK892800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER NEXGEN FEMORAL COMPONENT: CATALOG #: 00-5970-016-01, LOT #: 60020220. ZIMMER NEXGEN PRECOAT TIBIAL PLATE: CATALOG #: 00-5980-057-01, LOT #:NI. ZIMMER NEXGEN ALL-POLY PATELLA: CATALOG #: 00-5972-065-38, LOT # NI. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 1 OF 2 FOR THIS PATIENT. SEE ALSO 0001822565-2016-02812-2. VISUAL INSPECTION OF THE RETURNED FEMORAL COMPONENT IDENTIFIED THAT THE MEDIAL FEMORAL CONDYLE HAD FRACTURED OFF. BOTH PIECES WERE RETURNED. FOREIGN MATERIAL WAS NOTED ON THE BACKSIDE OF THE COMPONENT. SCRATCHES WERE NOTED IN THE COLOR BUFFED SURFACE. MEASURED DIMENSIONS WERE CONFORMING TO PRINT SPECIFICATIONS. SEM ANALYSIS OF THE FRACTURED SURFACE IDENTIFIED THAT IT WAS A FATIGUE FRACTURE. VISUAL INSPECTION OF THE RETURNED ARTICULAR SURFACE IDENTIFIED GOUGES AND PITTING ON THE CONDYLAR SURFACES. SEVERE WEAR WAS NOTED ON THE MEDIAL SIDE. WEAR WAS ALSO NOTED ON THE COMPONENT BACKSIDE. ACCURATE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE NOTED DAMAGE. INSPECTION OF THE RETURNED PATELLAR COMPONENT IDENTIFIED TWO OF THE PEGS HAD BEEN CUT OFF. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT AND ARTICULAR SURFACE IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. REVIEW OF THE X-RAYS FROM ONE WEEK BEFORE THE REVISION IDENTIFIED THE COMPONENTS APPEARED IN APPROPRIATE SIZE AND POSITION; HOWEVER, MARKED NARROWING BETWEEN THE FEMUR AND TIBIA ON THE MEDIAL SIDE WAS NOTED, INDICATING WEAR OR DISRUPTION OF THE ARTICULAR SURFACE. GROSS EVIDENCE OF LOOSENING OF THE COMPONENTS WAS ALSO NOTED. PER THE NEXGEN CR, PS, CRA, LPS, AND LCCK PACKAGE INSERT, PROSTHESIS FRACTURE IS A KNOWN RISK OF THIS PROCEDURE. EVALUATION OF THE RETURNED PRODUCTS INDICATES THAT THE FRACTURED FEMORAL COMPONENT CONTRIBUTED TO THE ARTICULAR SURFACE WEAR BY "SCOOPING" OUT THE POLY MATERIAL DURING ARTICULATION AFTER THE FRACTURE OCCURRED; HOWEVER, IT CANNOT BE DETERMINED IF THE ARTICULAR SURFACE WAS WORN PRIOR TO THE FRACTURE, WHICH MAY HAVE LED TO IMPROPER KINEMATICS AND INCREASED STRESS ON THE FEMORAL COMPONENT. A DEFINITIVE ROOT CAUSE OF THE FRACTURE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO CONDYLAR FRACTURE OF THE FEMORAL COMPONENT. POST-OPERATIVE X-RAYS REVEAL THAT THICKNESS OF THE ARTICULAR SURFACE IMPLANT HAD ALSO NARROWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531951 NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 60009260

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R