BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICONDYLAR KNEE SYSTEM

    MDR report key: 1192764 · Received October 8, 2008

    Report

    Report Number
    2530191-2008-00004
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    August 21, 2008
    Report Date
    October 3, 2008
    Manufacturer
    STELKAST, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INVESTIGATION - THE DEVICE HISTORY RECORDS OF THE UNICONDYLAR INLAY TIBIAL COMPONENT, LOT NUMBER 16474-001, AND UNICONDYLAR KNEE TIBIAL IMPLANT, LOT NUMBER 16474-000, WHICH MAKES UP THAT ASSEMBLY, WERE REVIEWED. THERE WAS NO MATERIAL OR DIMENSIONAL DISCREPANCIES NOTED IN THE RECORDS THAT MAY HAVE CONTRIBUTED TO THE DEBONDING. THE MATERIAL CERTIFICATION DATA OF THE IMPLANT CONFORMS TO THE REQUIREMENTS OF ASTM-F-648 AS SPECIFIED BY THE DRAWING. TEN (10) TIBIAL COMPONENTS WERE PRODUCED IN THIS LOT. A REVIEW OF THE STELKAST INCIDENT REPORT DATABASE INDICATES THAT THERE HAVE BEEN NO OTHER OCCURRENCES OF THIS CONDITION. CONCLUSION: NONE - BASED UPON THE INFO AVAILABLE AND RESULTS OF THE INVESTIGATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CONTRIBUTED TO THIS EVENT. ALSO, IT SHOULD BE NOTED THAT THE APPLICATION OF BONE CEMENT REQUIRES A SURGEON TO FOLLOW CERTAIN PROTOCOLS INVOLVED IN THE USE OF THE CEMENT. IT IS NOT POSSIBLE TO REVIEW THE SURGEON'S TECHNIQUE IN APPLYING THE CEMENT. THE INVESTIGATION DID NOT SHOW THAT A DESIGN DEFECT HAD CONTRIBUTED TO THE ORIGINAL COMPLAINT. THIS EVENT HAD NO ADVERSE AFFECT ON THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    PT REVISED DUE TO DEBONDING OF THE CEMENT FROM THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICONDYLAR KNEE SYSTEM JWH STELKAST, INC. 16474-061406

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention