BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR PROVISIONAL ARTICULAR SURFACE

    MDR report key: 2060972 · Received March 14, 2011

    Report

    Report Number
    1822565-2011-00577
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    November 6, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE PROVISIONAL IS FRACTURED ALONG THE CENTER OF THE INSTRUMENT. ADDITIONALLY, THE DEVICE EXHIBITS DAMAGE IN THE FORM OF NICKS, GOUGES AND SCRATCHES. THIS DAMAGE, COUPLED WITH THE PROVISIONAL'S APPROXIMATE 10 YEAR FIELD AGE, INDICATE THAT NORMAL WEAR IS THE CAUSE OF THIS INCIDENT. RETURNED ITEM WAS DIMENSIONALLY VERIFIED TO MEET PRINT SPECIFICATION; ITEM WAS MANUFACTURED CORRECTLY. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL ARTICULAR SURFACE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR PROVISIONAL ARTICULAR SURFACE KNEE INSTRUMENT JWH ZIMMER, INC. 41043100

    Patients

    Seq Age Sex Outcome Treatment
    1