BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZUK FEMORAL COMPONENT, HIGH FLEX

    MDR report key: 2103839 · Received May 24, 2011

    Report

    Report Number
    1822565-2011-01235
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: X-RAYS WERE NOT RETURNED FOR REVIEW. AS SUCH, THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. BASED ON THE AVAILABLE INFORMATION, THE EXACT CAUSE OF THE REPORTED PAIN AND LOOSENING CANNOT BE DETERMINED. EVALUATION: IMPLANT COMPATIBILITY WAS CONFIRMED. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND CHRONIC KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUK FEMORAL COMPONENT, HIGH FLEX HSX ZIMMER, INC. 61115734

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ZUK TIBIAL COMPONENT:| CATALOG #00584200301, LOT# 61090820| CATALOG #00584202308, LOT# 61055947| ZUK ARTICULAR SURFACE: