BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 19083335 · Received April 10, 2024

    Report

    Report Number
    0002249697-2024-00574
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 15, 2024
    Report Date
    August 19, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327382860
    PMA / PMN Number
    K173849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, 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 RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DAMAGE INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE PROVIDED PHOTOGRAPHS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: PHOTOGRAPHS WERE PROVIDED FOR REVIEW, SHOWING THE DEVICE HAS BEEN TAKEN OUT OF ITS PACKAGING AND HELD BY AN INDIVIDUAL. THE LOCKING WIRE APPEARS TO BE LOOSE. 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 THROUGH PI UNDER A MICROSCOPE WHERE EVIDENCE OF A WIRES PRESENCE WAS ENSURED. IT WAS OBSERVED THAT RESIDUAL SCRATCHES STEMMING FROM THE INSERTION OF THE LOCKING WIRE WERE PRESENT. ADDITIONALLY, ON THE MANUFACTURING ROUTER, LOCKIGN WIRE LOT 472832X1 WAS RECORDED. DESPITE THE LOCKING WIRE NOT HAVING BEEN RETURNED WITH THE COMPLAINT, WITH BOTH PHYSICAL AND DOCUMENTED EVIDENCE OF A LOCKING WIRE HAVING BEEN INSERTED IT CAN CONFIDENTLY BE STATED THAT A LOCKING WIRE WAS INSERTED DURING THE MANUFACTURING AND ASSEMBLY OF ASSEMBLY NUMBER 5530-G-409-E, TRIATHLON CR X3 TIBIAL INSERT LOT NUMBER 628XTM WITHIN THE TIBIAL PLASTICS CELL AT STRYKER MAHWAH, NJ. WITH THE MANUFACTURING ROUTER FOR ASSEMBLY NUMBER 5530-G-409-E, TRIATHLON CR X3 TIBIAL INSERT LOT NUMBER 628XTM SHOWING THAT THE LOCKING WIRE FEATURES WERE PROPERLY ASSEMBLED, INSPECTED, AND SIGNED OFF ON BY TRAINED OPERATOR(S) IT CAN BE SAID WITH CONFIDENCE THAT THE 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 THE LOCKING MECHANISM WAS SPOTTED DEFECT UPON IMPLANTATION. VISUAL INSPECTION: PHOTOGRAPHS WERE PROVIDED FOR REVIEW, SHOWING THE DEVICE HAS BEEN TAKEN OUT OF ITS PACKAGING AND HELD BY AN INDIVIDUAL. THE LOCKING WIRE APPEARS TO BE LOOSE. 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 THROUGH PI UNDER A MICROSCOPE WHERE EVIDENCE OF A WIRES PRESENCE WAS ENSURED. IT WAS OBSERVED THAT RESIDUAL SCRATCHES STEMMING FROM THE INSERTION OF THE LOCKING WIRE WERE PRESENT. ADDITIONALLY, ON THE MANUFACTURING ROUTER, LOCKIGN WIRE LOT 472832X1 WAS RECORDED. DESPITE THE LOCKING WIRE NOT HAVING BEEN RETURNED WITH THE COMPLAINT, WITH BOTH PHYSICAL AND DOCUMENTED EVIDENCE OF A LOCKING WIRE HAVING BEEN INSERTED IT CAN CONFIDENTLY BE STATED THAT A LOCKING WIRE WAS INSERTED DURING THE MANUFACTURING AND ASSEMBLY OF ASSEMBLY NUMBER 5530-G-409-E, TRIATHLON CR X3 TIBIAL INSERT LOT NUMBER 628XTM WITHIN THE TIBIAL PLASTICS CELL AT STRYKER MAHWAH, NJ. WITH THE MANUFACTURING ROUTER FOR ASSEMBLY NUMBER 5530-G-409-E, TRIATHLON CR X3 TIBIAL INSERT LOT NUMBER 628XTM SHOWING THAT THE LOCKING WIRE FEATURES WERE PROPERLY ASSEMBLED, INSPECTED, AND SIGNED OFF ON BY TRAINED OPERATOR(S) IT CAN BE SAID WITH CONFIDENCE THAT THE THE TIBIAL PLASTICS TRIATHLON INSERT LEFT THE TIBIAL PLASTICS MANUFACTURING CELL WITH THE LOCKING WIRE PRESENT AND APPROPRIATELY ASSEMBLED." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT THE TRIATHLON X3 TIBIAL BEARING INSERT METAL CLIP THAT SERVE AS A LOCKING MECHANISM WAS SPOTTED DEFECT UPON IMPLANTATION. A REPLACEMENT IMPLANT WAS USED TO COMPLETE THE SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT THE TRIATHLON X3 TIBIAL BEARING INSERT METAL CLIP THAT SERVE AS A LOCKING MECHANISM WAS SPOTTED DEFECT UPON IMPLANTATION. A REPLACEMENT IMPLANT WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925493 TRIATHLON CR X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 628XTM 07613327382860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H| R