BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN RHK FEMORAL COMPONENT

    MDR report key: 2031165 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00697
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVAL. POST-OPERATIVE X-RAYS CONFIRM BRAKEAGE OF FEMORAL STEM COMPONENT, BUT THE REASON FOR BREAKAGE IS UNK, ALTHOUGH SURGEON MENTIONS THE NATIVE CONDYLES HAD RESORBED AND PT'S WEIGHT WAS 100% LOADED ON THE STEM EXTENSION JUNCTION. BONE RESORPTION COULD BE DUE TO INFECTION OR PT INJURY. DUE TO UNAVAILABLE PT HISTORY, THIS CANNOT BE CONFIRMED. THERE ARE ALSO NO INTERMEDIATE FOLLOW UP REPORTS OF PT VISITS WHICH COULD HAVE GIVEN AN INSIGHT TO THE ALLEGED DEFICIENCY. WITH THE AVAILABLE INFO, THE PROBABLE CAUSE FOR THE BREAKAGE OF FEMORAL STEM COMPONENT CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT KNEE REVISION SURGERY. THE PROXIMAL END OF FEMORAL COMPONENT WHICH ACCEPTS STEM EXTENSION WAS NOTED AS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN RHK FEMORAL COMPONENT KRO ZIMMER, INC. 79734000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention