BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2153166 · Received June 23, 2011

    Report

    Report Number
    1822565-2011-01500
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Removal / Correction Number
    1822565-04/19/2010-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REQUEST FOR DEVICES AND X-RAYS WERE DENIED BY HOSPITAL AND SURGEON. WITHOUT FURTHER INFO ON SURGERY AND/OR RETURN OF PRODUCTS AND/OR X-RAYS, THE PROBABLE CAUSE FOR THE PT'S PAIN & LOOSENING CANNOT BE DETERMINED. A FIELD ACTION WAS CONDUCTED ON (B)(6) 2010 PER CORRECTION NUMBER 1822565-04/19/2010-001C, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO LOOSENING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER INC 60732159

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention