BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON CS INSERT NO 7 16MM

    MDR report key: 20402029 · Received October 8, 2024

    Report

    Report Number
    0002249697-2024-01382
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 4, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327337198
    PMA / PMN Number
    K172634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION IS UNDER REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISASSOCIATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA INSPECTION OF THE RETURNED DEVICE. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCKING WIRE IS DISASSOCIATED. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "ON THE MANUFACTURING ROUTER, LOCKING WIRE LOT 012501X1 WAS RECORDED, SEE THE ATTACHED ROUTER. WITH DOCUMENTED EVIDENCE OF A LOCKING WIRE HAVING BEEN ASSEMBLED IT CAN CONFIDENTLY BE STATED THAT A LOCKING WIRE WAS ASSEMBLED AND INSPECTED DURING THE MANUFACTURING AND ASSEMBLY OF ASSEMBLY NUMBER 5531-G-716-E, TRIATHLON CS X3 TIBIAL INSERT LOT NUMBER MW7XM0 WITHIN THE TIBIAL PLASTICS CELL AT STRYKER MAHWAH, NJ." 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 WIRE WAS OBSERVED TO BE SEPARATED FROM THE INSERT UPON OPENING THE DEVICE PACKAGING DURING SURGERY. VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCKING WIRE IS DISASSOCIATED. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "ON THE MANUFACTURING ROUTER, LOCKING WIRE LOT 012501X1 WAS RECORDED. WITH DOCUMENTED EVIDENCE OF A LOCKING WIRE HAVING BEEN ASSEMBLED IT CAN CONFIDENTLY BE STATED THAT A LOCKING WIRE WAS ASSEMBLED AND INSPECTED DURING THE MANUFACTURING AND ASSEMBLY OF ASSEMBLY NUMBER 5531-G-716-E, TRIATHLON CS X3 TIBIAL INSERT LOT NUMBER MW7XM0 WITHIN THE TIBIAL PLASTICS CELL AT STRYKER MAHWAH, NJ." THE GQO TEAM ALSO PERFORMED A REVIEW OF THE DHR AND INDICATED THAT BASED ON THE DHR RECORD REVIEW, IT CAN BE CONCLUDED THAT ALL PACKAGING MANUFACTURING STEPS WERE PERFORMED ACCORDING TO THE APPLICABLE PROCEDURES WITH NO DISCREPANCIES RELATED TO THE LOCKING WIRE PRESENCE AND THAT THE SEALED PACKAGE LEFT STRYKER MAHWAH WITH NO ISSUES. 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

    PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT WHEN THE INNER BLISTER WAS OPENED, ONE SIDE OF THE LOCKING WIRE WAS DETACHED/SITTING UP FROM THE INSERT. REP WAS PRESENT FOR AN WITNESS TO THE EVENT. A SECOND IMPLANT WAS OBTAINED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE. 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 WHEN THE INNER BLISTER WAS OPENED, ONE SIDE OF THE LOCKING WIRE WAS DETACHED/ SITTING UP FROM THE INSERT. REP WAS PRESENT FOR AN WITNESS TO THE EVENT. A SECOND IMPLANT WAS OBTAINED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE. 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
    16090 X3 TRIATHLON CS INSERT NO 7 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH MW7XM0 07613327337198

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other