BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 2051055 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00853
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    December 20, 2010
    Report Date
    March 8, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. DISLOCATION CAN BE ASSOCIATED WITH A NUMBER OF MECHANISMS. UNSATISFACTORY PLACEMENT OF THE COMPONENT PARTS. EXTENT OF COMPONENT STABILITY. IF COMPONENTS THAT WERE NOT MATCHED FOR THE PT REQUIREMENTS ARE USED, THIS MAY INCREASE THE INSTABILITY OF THE JOINT. EXTENT OF SOFT TISSUE TENSION. INADEQUATE SOFT TISSUE TENSION AND/OR POOR FUNCTIONAL MUSCLES AROUND THE HIP MAY NOT BE ABLE TO PROVIDE FUNCTIONAL SUPPORT TO THE JOINT. PT BEHAVIOR. THERE IS INSUFFICIENT INFO TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 INFO 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 PRESENTED FOR SECOND DISLOCATION FOLLOWING PRIMARY SURGERY. DISLOCATION WAS REPLACED THROUGH A CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM LONGEVITY CROSSLINKED POLY LINER JDI ZIMMER INC 61365990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention