BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 1846108 · Received September 21, 2010

    Report

    Report Number
    1822565-2010-00792
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    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

    EVALUATION SUMMARY: WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION FOR. ZIMMER CORRECTION # 1822565-04/19/2010-001-C WAS ISSUED TO ENHANCE THE LABELING FOR THE NEXGEN MIS STEMMED TIBIAL COMPONENT. THE IMPLANTATION DATE IS PRIOR TO THE CORRECTION. 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. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60644380

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention