BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER MIS TIBIAL COMPONENT

    MDR report key: 1845463 · Received September 15, 2010

    Report

    Report Number
    1822565-2010-00694
    Event Type
    Injury
    Date Received
    September 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION ACTION IN APRIL 2010. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO UNK LOT NUMBER. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. GIVEN THE INFO AVAILABLE THE ASSESSMENT COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. A FIELD ACTION WAS CONDUCTED ON APRIL 19, 2010 PER 1822565-04/19/2010-001, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE. IT IS ASSUMED THE DEVICE IN QUESTION WAS IMPLANTED PRIOR TO THIS FIELD ACTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO 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