BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON CS INSERT NO 4 9MM

    MDR report key: 20199669 · Received September 12, 2024

    Report

    Report Number
    0002249697-2024-01260
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 22, 2024
    Report Date
    January 14, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327337150
    PMA / PMN Number
    K172634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCKING WIRE HAS SEPARATED FROM THE POLYETHYLENE TIBIAL INSERT. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "WITH THE MANUFACTURING ROUTER FOR ASSEMBLY NUMBER 5531-G-409-E, TRIATHLON CS X3 TIBIAL INSERT LOT NUMBER R3031H SHOWING THAT THE LOCKING WIRE FEATURES WERE PROPERLY INSPECTED AND SIGNED OFF ON BY TRAINED OPERATOR(S) AND VISUAL EVIDENCE UNDER A MICROSCOPE OF THE PRESENCE OF A LOCKING WIRE IT CAN BE SAID WITH CONFIDENCE THAT THE TIBIAL PLASTICS TRIATHLON INSERT LEFT THE TIBIAL PLASTICS MANUFACTURING CELL WITH THE LOCKING WIRE PRESENT AND APPROPRIATELY ASSEMBLED." CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT IMMEDIATELY AFTER REMOVING THE INSERT FROM THE STERILE BLISTER, THE LOCKING WIRE FELL OFF OF THE INSERT. VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCKING WIRE HAS SEPARATED FROM THE POLYETHYLENE TIBIAL INSERT. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "WITH THE MANUFACTURING ROUTER FOR ASSEMBLY NUMBER 5531-G-409-E, TRIATHLON CS X3 TIBIAL INSERT LOT NUMBER R3031H SHOWING THAT THE LOCKING WIRE FEATURES WERE PROPERLY INSPECTED AND SIGNED OFF ON BY TRAINED OPERATOR(S) AND VISUAL EVIDENCE UNDER A MICROSCOPE OF THE PRESENCE OF A LOCKING WIRE IT CAN BE SAID WITH CONFIDENCE THAT THE TIBIAL PLASTICS TRIATHLON INSERT LEFT THE TIBIAL PLASTICS MANUFACTURING CELL WITH THE LOCKING WIRE PRESENT AND APPROPRIATELY ASSEMBLED." IT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED THAT THE REPORTED ISSUE RESULTED FROM MANUFACTURING. FURTHERMORE, IT IS POSSIBLE THAT THE LOCKING WIRE DISLODGED DURING TRANSPORTATION/HANDLING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT IMMEDIATELY AFTER REMOVING THE INSERT FROM THE STERILE BLISTER, THE LOCKING WIRE FELL OFF OF THE INSERT. THE INSERT DID NOT COME IN CONTACT WITH THE PATIENT. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. REP WAS PRESENT FOR AND WITNESS TO THIS EVENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Description of Event or Problem · 0

    PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT IMMEDIATELY AFTER REMOVING THE INSERT FROM THE STERILE BLISTER, THE LOCKING WIRE FELL OFF OF THE INSERT. THE INSERT DID NOT COME IN CONTACT WITH THE PATIENT. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. REP WAS PRESENT FOR AND WITNESS TO THIS EVENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574152 X3 TRIATHLON CS INSERT NO 4 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH R3031H 07613327337150

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other