BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 19151166 · Received April 22, 2024

    Report

    Report Number
    0002249697-2024-00621
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327050776
    PMA / PMN Number
    K051146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE
    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 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.

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING DISASSOCIATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS CONFIRMED VIA PROVIDED PHOTOGRAPHS OF THE EVENT. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCKING WIRE IS NOT PRESENT. NO OBVIOUS DAMAGE IS VISIBLE. ADDITIONALLY, PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW THE DEVICE IN AN OPENED BLISTER PACKAGING WITH THE LOCKING WIRE LOOSE INSIDE THE PACKAGING. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "FURTHER INVESTIGATION CONDUCTED WAS THE EXAMINATION OF THE COMPLAINT PART RETURNED BACK TO STRYKER THROUGH PI # 3588544 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, LOCKING WIRE LOT 012652X10 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 5532-G-509-E, TRIATHLON PS X3 TIBIAL INSERT LOT NUMBER HP8LER 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 NOT PRESENT. NO OBVIOUS DAMAGE IS VISIBLE. ADDITIONALLY, PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW THE DEVICE IN AN OPENED BLISTER PACKAGING WITH THE LOCKING WIRE LOOSE INSIDE THE PACKAGING. THE DEVICE WAS FURTHER REVIEWED BY THE GLOBAL QUALITY & OPERATIONS (GQO) TEAM WHICH INDICATED THE FOLLOWING: "FURTHER INVESTIGATION CONDUCTED WAS THE EXAMINATION OF THE COMPLAINT PART RETURNED BACK TO STRYKER THROUGH PI # 3588544 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, LOCKING WIRE LOT 012652X10 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 5532-G-509-E, TRIATHLON PS X3 TIBIAL INSERT LOT NUMBER HP8LER WITHIN THE TIBIAL PLASTICS CELL AT STRYKER MAHWAH, NJ." 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 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 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.

    Description of Event or Problem · 0

    DURING THE PREPARATION OF IMPLANTS FOR IMPLANTATION, DAMAGE TO THE BRAND NEW PRODUCT WAS FOUND. FOLLOWING THE INCIDENT, THE IMPLANT WAS REPLACED WITH A NEW ONE OF THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY DELAYS.

    Description of Event or Problem · 0

    DURING THE PREPARATION OF IMPLANTS FOR IMPLANTATION, DAMAGE TO THE BRAND NEW PRODUCT WAS FOUND. FOLLOWING THE INCIDENT, THE IMPLANT WAS REPLACED WITH A NEW ONE OF THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT ANY DELAYS. PRODUCT REF (B)(4). UPDATE: THE LOCKING WIRE WAS ORIGINALLY SEPARATED FROM THE POLYETHYLENE. THE DEFECT WAS OBSERVED IMMEDIATELY AFTER OPENING THE IMPLANT PACKAGE. NO ATTEMPT WAS MADE TO INSTALL THE DAMAGED INSERT. IT WAS DECIDED TO OPEN ANOTHER IMPLANT AND INSERT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2592580 TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH HP8LER 07613327050776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other