BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-LEG/C-LEG TUBE ADAPTER

    MDR report key: 1060404 · Received June 27, 2008

    Report

    Report Number
    9615892-2008-00001
    Event Type
    Injury
    Date Received
    June 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Product Code
    ISW
    PMA / PMN Number
    K991590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MODIFIED DEVICE CODES FROM DOMPLETED DEVICE EVAL REPORT. MODIFIED EVAL RESULTS AND CONCLUSIONS FROM COMPLETED DEVICE EVAL REPORT. CONCLUSION: THE OBSERVED FAILURE HAS BEEN PREVIOUSLY REPORTED AND IDENTIFIED. SUITABLE MEASURES HAVE ALREADY BEEN IMPLEMENTED. THE BONDING PROCESS FOR TUBE AND ADAPTER HAS BEEN REVISED AND OPTIMISED. SIGNIFICANT IMPROVEMENT OF THE BONDING HAS BEEN OBTAINED BY INTRODUCING SANDBLASTING INTO THE PRODUCTION PROCESS PRIOR TO BONDING. BECAUSE GOOD RESULTS WERE ACHIEVED ONCE SANDBLASTING HAD BEEN INTRODUCED TO THE PRODUCTION PROCESS, IT WAS CONCLUDED THAT THIS COMPLEMENTARY MFG STEP IS SUFFICIENT AND NO ADD'L MEASUERES ARE NECESSARY. THE C-LEG TUBE THAT RESULTED IN THE MENTIONED INCIDENT BELONGS TO OLDER PROD GENERATION PRIOR TO INTRODUCTION OF SANDBLASTING INTO MFG PROCESS. IN MOST CASES, THE CHANGE OF THE SIGNALS WHICH RESULTS FROM A BONDING PROBLEM BETWEEN TUBE AND ADAPTOR AND COULD POTENTIALLY LEAD TO THE SWING PHASE BEING MORE EASILY RELEASED RESULTS IN A GRADUAL RATHER THAN ABRUPT CHANGE OF BEHAVIOUR. THE PT WILL USUALLY NOTICE THIS GRADUAL CHANGE IN THE BEHAVIOR OF THE PROSTHESES AND WILL VISIT A CPO BEFORE THE FALL BY AN UNINTENTIONAL RELEASE OF THE SWING PHASE TAKES PLACE. THE YEARLY PRESCRIBED SVC OF THE KNEE JOINT ALSO INVOLVES AN EXAMINATION OF THE SIGNALS. IF THE VALUES DURING THE EXAMINATION LIE OUTSIDE THE TOLERANCE AREA OR WITHIN THE TOLERANCE AREA, BUT A TREND FOR VALUES TO DRIFT IS OBSERVED, THE AFFECTED TUBE IS EXCHANGED. ADDITIONALLY, A NEW TEST WHICH CHECKS THE QUAL OF THE BONDING BETWEEN TUBE AND ADAPTOR WAS INTRODUCED IN THE REGULAR SVC.

    Description of Event or Problem · 1

    THE PT WAS ON THE WAY TO THE HOSP WHEN THE STANCE PHASE DAMPING OF THE KNEE JOINT FAILED. THE PT FELL AND INCURRED A SPLINTERING OF THE BONE WHICH HAD TO BE OPERATED ON IN THE HOSP. POSSIBLE REASON FOR THE FAILURE WAS A DEFECT OF THE C-LEG TUBE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-LEG/C-LEG TUBE ADAPTER ISW / ISY ISW OTTO BOCK HEALTHCARE PRODUCTS GMBH 3C88/2R91=160

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization