BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2624469 · Received June 13, 2012

    Report

    Report Number
    1822565-2012-01259
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    August 5, 2011
    Report Date
    May 14, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-04/19/2010-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION IN (B)(6) 2010. A FIELD ACTION WAS CONDUCTED ON (B)(6) 2010 PER RECALL NUMBER 1822565-04/19/2010-001, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DRIP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE. THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION. EVAL: 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60983701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN LPS-FLEX GSF FEMORAL COMPONENT:| CAT# 00576401452, LOT# 60936485