BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER ULNA ASSEMBLY

    MDR report key: 2230794 · Received August 23, 2011

    Report

    Report Number
    1822565-2011-01926
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED (B)(4) IS MOSTLY COVERED IN BONE CEMENT. THE BUSHINGS ARE DEFORMED AND SHOW WEAR WHICH IS MOST LIKELY DUE TO THEIR USE OVER (B)(6) IN VIVO. THE ETCHING ON THE INNER AND OUTER PINS HAS WORN AWAY, AGAIN MOST LIKELY DUE TO THEIR USE OVER (B)(6) IN VIVO. THE OPERATIVE NOTES DURING THE 2000 REVISION INDICATE THAT THE ULNA COMPONENT WAS STABLE AND REINFORCED WITH ADDITIONAL BONE CEMENT. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE LOT NUMBERS ARE UNKNOWN AND UNAVAILABLE FOR ANY OF THE COMPONENTS THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE ACCOMPLISHED. THE RETURNED PINS AND ULNA WERE DIMENSIONALLY ANALYZED AND FOUND TO BE CONFORMING WERE MEASURED. THE BUSHINGS ARE WORN THEREFORE THEY WERE NOT DIMENSIONALLY ANALYZED. 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. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER ULNA ASSEMBLY JDB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention