BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

    MDR report key: 2358534 · Received November 23, 2011

    Report

    Report Number
    1822565-2011-02616
    Event Type
    Injury
    Date Received
    November 23, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS OF THE REVISION SURGERY RETURNED ARE TOO SMALL TO MAKE OUT ANY DETAIL OF THE KNEE JOINT. PHOTOGRAPHS OF THE FEMORAL COMPONENT SHOW THAT IT IS FRACTURED INTO TWO PIECES. THE FRACTURE OCCURRED ACROSS THE M/L DIRECTION, SLIGHTLY ANTERIOR TO THE PEG LOCATED POSTERIORLY. PHOTOGRAPHS OF THE ARTICULAR SURFACE SHOW THAT IT IS SEVERELY WORN AND THERE IS A SMALL SECTION OF POLY MATERIAL THAT APPEARS SLIGHTLY DETACHED. THIS PIECE OF MATERIAL WAS MOST LIKELY DISTURBED DURING THE IMPLANT REMOVAL PROCESS. THE X-RAYS PROVIDED SHOW THAT THE ARTICULAR SURFACE IS SEVERELY WORN, AS THERE IS LITTLE TO NO SPACE SEEN BETWEEN THE FEMORAL AND TIBIAL COMPONENTS. IN THE X-RAYS PROVIDED, IT IS NOT APPARENT THAT THE FEMORAL COMPONENT HAS FRACTURED. THE TIBIAL COMPONENT SEEMS TO BE SIZED WELL IN THE M/L DIRECTION, BUT APPEARS SLIGHTLY UNDERSIZED IN THE A/P DIRECTION. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD A LARGE BUILD, HIGH BMI, AND WAS HIGHLY ACTIVE DURING THE SIX YEARS THE COMPONENTS WERE IMPLANTED. THIS COULD HAVE CONTRIBUTED TO THE FRACTURE OF THE FEMORAL COMPONENT. THE EXACT CAUSE OF THIS EVENT, HOWEVER, CANNOT BE DETERMINED AT THIS TIME. 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 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN. SEVERE POLY WEAR WAS NOTED AND THE FEMORAL COMPONENT WAS FRACTURED. SURGEON STATED THAT THE PATIENT HAD BEEN RUNNING FOR THE PAST SEVERAL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT HSX ZIMMER, INC. 60147257

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention