BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE

    MDR report key: 1659705 · Received April 13, 2010

    Report

    Report Number
    1822565-2010-00218
    Event Type
    Injury
    Date Received
    April 13, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PRODUCT OR X-RAYS WERE RETURNED FOR REVIEW. IT IS KNOWN THAT THE PT IS A (B) (6) FEMALE, HOWEVER, OTHER PT DETAILS ARE UNK. WITH THE AVAILABLE INFO, THE CAUSE OF THE REPORTED LOOSENING THAT LED TO REVISION CAN NOT BE DETERMINED, HOWEVER, A CAPA HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION OF THIS ISSUE. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE SURGEON HAD TO REVISE THE TIBIAL COMPONENT DUE TO EARLY LOOSENING. THE IMPLANT (AS SEEN ON X-RAY) SUBSIDED ON THE MEDIAL SIDE AND NEEDED TO BE REVISED. NO STEM EXTENSION WAS USED ON THIS PT.

    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 61116566

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention