BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNI KNEE FEMORAL COMPONENT

    MDR report key: 2023285 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00580
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    September 11, 2009
    Report Date
    September 16, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: THE LABEL WAS VERIFIED TO INDICATE USE FOR THE RIGHT MEDIAL/ LEFT LATERAL SIDE. SINCE THE DEVICE REMAINS IMPLANTED, IT WAS NOT RETURNED FOR EVALUATION; NOR WERE ANY X-RAYS RETURNED FOR EVALUATION. AT THIS TIME, THE CAUSE OF THE COMPLAINT APPEARS TO BE SURGEON CONFUSION. 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 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 INCORRECT DEVICE WAS IMPLANTED INTO THE RIGHT KNEE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNI KNEE FEMORAL COMPONENT HSX ZIMMER, INC. 61216278

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other