BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM TM SHELL WITH CLUSTER HOLES

    MDR report key: 2162025 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01630
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES WERE PROVIDED FROM THE IMPLANTATION SURGERY ON (B)(6) 2010 WHERE THE SHELL WAS DESCRIBED AS HAVING EXCELLENT IMMEDIATE PRESS-FIT STABILITY. IT WAS DESCRIBED THAT THE LEG LENGTHS WERE EQUAL AND HIP WAS STABLE. X-RAYS WERE NOT PROVIDED; IT COULD NOT BE CONFIRMED THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. SURGICAL NOTES WERE PROVIDED FROM THE REVISION ON (B)(6) 2011 WHICH WAS CARRIED OUT DUE TO THE SHELL LOOSENING AFTER A FALL. DETAILS OF THE CIRCUMSTANCES LEADING UP TO THE FALL WERE NOT DESCRIBED. THE ROOT CAUSE OF THIS REPORT IS MOST LIKELY THE PT FALL LEADING TO THE ACETABULAR COMPONENT LOOSENING. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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 PT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TM SHELL WITH CLUSTER HOLES JDI ZIMMER INC 61675381

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention