BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    MDR report key: 2000902 · Received February 18, 2011

    Report

    Report Number
    1822565-2011-00281
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    February 9, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-4/19/2010-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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 APRIL 2010. EVAL: NO PRODUCT WAS RETURNED. NO ITEM AND LOT INFO WAS PROVIDED, THEREFORE, REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. A FIELD ACTION WAS CONDUCTED ON 4/19/2010, 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention