BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE

    MDR report key: 1666478 · Received April 22, 2010

    Report

    Report Number
    1822565-2010-00246
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. IT IS KNOWN THAT THE PATIENT IS A FEMALE, HOWEVER, OTHER PATIENT DETAILS ARE UNKNOWN. WITH THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED LOOSENING THAT LED TO REVISION CANNOT BE DETERMINED. COMPLAINTS OF THIS NATURE WILL BE CONTINUOUSLY MONITORED FOR ANY ADVERSE TRENDS. EVALUATION: NO PRODUCT WAS RETURNED. 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

    PATIENT REPORTS PAIN THAT BEGAN ABOUT 8 MO AFTER THA. PATIENT REPORTS THAT THE KNEE IMPLANT IS LOOSE AND REVISED ON (B) (6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE KNEE PROSTHESIS JWH ZIMMER, INC. NA 60845502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention