BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 16901543 · Received May 10, 2023

    Report

    Report Number
    0002249697-2023-00496
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 17, 2023
    Report Date
    September 1, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327338560
    PMA / PMN Number
    K141056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING APPEARANCE 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 DEVICE IS DAMAGED/DEFORMED IN THE AREA OF THE LOCKING MECHANISM. IN ADDITION, THE LOCKING WIRE APPEARS TO BE BENT AND PARTIALLY DISASSOCIATED. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHO INDICATED THE FOLLOWING: "FURTHER INVESTIGATION CONDUCTED WAS THE EXAMINATION OF THE COMPLAINT PART RETURNED BACK TO STRYKER UNDER A MICROSCOPE WHERE EVIDENCE OF A WIRES PRESENCE AND IT HAVING BEEN FULLY SEATED WITHIN THE LOCKING WIRE SLOT WAS ENSURED. IT WAS OBSERVED THAT RESIDUAL SCRATCHES STEMMING FROM THE INSERTION OF THE LOCKING WIRE WERE PRESENT." 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 THE INSERT WAS OBSERVED TO BE NOT IN PERFECT CONDITIONS UPON OPENING THE DEVICE PACKAGING. VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE DEVICE IS DAMAGED/DEFORMED IN THE AREA OF THE LOCKING MECHANISM. IN ADDITION, THE LOCKING WIRE APPEARS TO BE BENT AND PARTIALLY DISASSOCIATED. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHO INDICATED THE FOLLOWING: "FURTHER INVESTIGATION CONDUCTED WAS THE EXAMINATION OF THE COMPLAINT PART RETURNED BACK TO STRYKER UNDER A MICROSCOPE WHERE EVIDENCE OF A WIRES PRESENCE AND IT HAVING BEEN FULLY SEATED WITHIN THE LOCKING WIRE SLOT WAS ENSURED. IT WAS OBSERVED THAT RESIDUAL SCRATCHES STEMMING FROM THE INSERTION OF THE LOCKING WIRE WERE PRESENT." THE GQO TEAM ALSO PERFORMED A REVIEW OF THE DHR AND INDICATED THAT "THE LOCKING WIRE FEATURES WERE PROPERLY INSPECTED AND SIGNED OFF ON BY TRAINED OPERATOR(S)" AND THAT "THERE WERE NO NOTED DISCREPANCIES OR ANOMALIES" IN SUBSEQUENT PROCESSING STEPS. 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 HANDLING OR TRANSPORTATION. 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. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 0

    IT WAS REPORTED: "THE CUSTOMER INFORMED THAT WHEN AT THE OPENING OF THE IMPLANT, IT WAS NOT IN PERFECT CONDITION TO BE IMPLANTED¿. A PICTURE HAS BEEN PROVIDED AND SHOWS THE LOCKING WIRE IS NOT IN PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED: "THE CUSTOMER INFORMED THAT WHEN AT THE OPENING OF THE IMPLANT, IT WAS NOT IN PERFECT CONDITION TO BE IMPLANTED¿. A PICTURE HAS BEEN PROVIDED AND SHOWS THE LOCKING WIRE IS NOT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881412 TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5532-G-413-E Y862NE 07613327338560

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other