BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CS INS SIZE 6 11MM

    MDR report key: 9537187 · Received January 1, 2020

    Report

    Report Number
    0002249697-2020-00006
    Event Type
    Malfunction
    Date Received
    January 1, 2020
    Date of Event
    December 3, 2019
    Report Date
    February 26, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327042382
    PMA / PMN Number
    K141056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING AN APPEARANCE ISSUE (SCRATCH) INVOLVING A TRIATHLON INSERT WAS REPORTED. THE REPORTED LINES WERE VISIBLE HOWEVER THEY REPRESENT MARKINGS TYPICALLY ASSOCIATED WITH THE MANUFACTURING PROCESS. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE REPORTED DEVICE WITH AN OPENED BLISTER, UNIT CARTON AND IFU WAS RETURNED FOR EVALUATION. THE PHYSICAL PARTS WERE VISUALLY EXAMINED BY THE HDP CELL MANUFACTURING ENGINEER AND THE CELL QUALITY ENGINEER, BUT NO SCRATCH WAS VISIBLE. THE DEVICE WAS ALSO VISUALLY INSPECTED BY HDP VISUAL INSPECTOR AS PER QA3-022 AND PROCESSED THROUGH CMM AS PER D03751 BUT WAS FOUND NOT TO HAVE ANY MARKINGS/RIDGES OTHER THAN THOSE TYPICALLY ASSOCIATED WITH THE MANUFACTURING PROCESS. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. IT WAS ALSO NOTED THAT THESE PARTS ALSO PASSED ALL VISUAL AND CMM INSPECTIONS AT THE TIME OF MANUFACTURING. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: UPON RETURN, THE PHYSICAL PARTS WERE VISUALLY EXAMINED BY THE HDP CELL MANUFACTURING ENGINEER AND THE CELL QUALITY ENGINEER, BUT NO SCRATCH WAS VISIBLE. THE DEVICE WAS ALSO VISUALLY INSPECTED BY HDP VISUAL INSPECTOR AS PER QA3-022 AND PROCESSED THROUGH CMM AS PER D03751 BUT WAS FOUND NOT TO HAVE ANY MARKINGS/RIDGES OTHER THAN THOSE TYPICALLY ASSOCIATED WITH THE MANUFACTURING PROCESS. IT WAS ALSO NOTED THAT THESE PARTS ALSO PASSED ALL VISUAL AND CMM INSPECTIONS AT THE TIME OF MANUFACTURING. THEREFORE, IT CAN BE CONCLUDED THAT THE PART IN QUESTION MEETS ALL THE REQUIREMENTS AND HAS BEEN MANUFACTURED TO THE REQUIRED SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LARGE SCRATCH ON THE INSERT. THIS WAS NOTICED DURING PREPARATION FOR A PROCEDURE, PRIOR TO INSERTION. A NEW INSERT WAS USED INSTEAD.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LARGE SCRATCH ON THE INSERT. THIS WAS NOTICED DURING PREPARATION FOR A PROCEDURE, PRIOR TO INSERTION. A NEW INSERT WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84 TRIATHLON CS INS SIZE 6 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5531-P-611 LJD714 07613327042382

    Patients

    Seq Age Sex Outcome Treatment
    1 Other