BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2669775 · Received July 20, 2012

    Report

    Report Number
    1822565-2012-01544
    Event Type
    Injury
    Date Received
    July 20, 2012
    Date of Event
    July 11, 2011
    Report Date
    March 16, 2020
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    K031061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. MEDICAL PRODUCTS: CR-FLEX POR FEM E-R; P/N: 00595201502, L/N: 61161887; NEXGEN TM TIB COMPONENT, SZ 6; P/N: 00595404702, L/N: 61068767; XLPE CR ART SURF CH56/GRN 17; P/N: 90595204017, L/N: 61023242; NEXGEN MIS TM FLEX SCREW; P/N: 00595409000, L/N: 61017079. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED COMPONENTS (FEMORAL IMPLANT, ARTICULAR SURFACE) NOTED THAT THEY EXHIBIT SIGNS OF BEING IMPLANTED. THE BACKSIDE OF THE FEMORAL IMPLANT IS MOSTLY FREE OF BIOLOGICAL REMAINS WITH SOME FIBROUS/BONY REMAINS ANCHORED TO THE POROUS COATING ONLY IN FEW RANDOM LOCATIONS. THE BUFFED CONDYLAR SURFACES ARE WORN. ONLY THE LATERAL CONDYLAR SURFACE OF THE ARTICULAR SURFACE FEATURES A SMALL SCRATCH IN THE POSTERO-LATERAL REGION. DIMENSIONAL ANALYSIS OF THE FEMORAL IMPLANT PASSED WHERE MEASURED. PER THE INSTRUCTIONS FOR USE OF THE IMPLANTS, PAIN, AND LOOSENING OF THE PROSTHETIC KNEE COMPONENTS ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE TKA PROCEDURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS ALLEGING HARM CAUSED BY THE DEVICE, HOWEVER, THE NATURE OF THE HARM IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 61161887

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R