BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN RHK ARTICULAR SURFACE

    MDR report key: 2023276 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00551
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE CONDITION OF THE COMPONENTS GIVES NO INDICATION THAT THE INSTABILITY WAS RELATED TO ANYTHING OTHER THAN THE REPORTED FALL. NO X-RAYS OR OTHER INFO WAS REPORTED TO ZIMMER. WITHOUT ADDITIONAL INFO, THE EXACT CAUSE OF THIS INCIDENT (I.E. RELATED TO THE REPORTED FALL OR NOT) CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION : REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO 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 PT WAS REVISED FOR INSTABILITY AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN RHK ARTICULAR SURFACE KRO ZIMMER, INC. 60512428

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention