BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR INSERT X3 NO 5 RM/LL -8MM

    MDR report key: 20186311 · Received September 10, 2024

    Report

    Report Number
    0002249697-2024-01250
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 10, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    07613327015669
    PMA / PMN Number
    K082567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING INCORRECT SELECTION INVOLVING AN TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. 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 A TRIATHLON PKR INSERT WAS IMPLANTED WITH A RESTORIS MCK FEMORAL OF A RESTORIS MCK INSERT. THE DISCOVERY WAS MADE POST-OPERATIVELY, AND THE PATIENT WAS REVISED. THE EVENT IS CONSIDERED TO BE THE RESULT OF USER ERROR AS NO MANUFACTURING-RELATED PRODUCT PROBLEM WAS FOUND GIVEN THE INFORMATION PROVIDED. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO REVIEW THE DEVICE LABEL PRIOR TO IMPLANTATION. 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

    THE FOLLOWING WAS REPORTED: "PRIMARY PROCEDURE, RIGHT MEDIAL MAKO UNI. IT WAS REPORTED THAT A TRIATHLON PKR INSERT WAS IMPLANTED WITH A RESTORIS MCK FEMORAL COMPONENT AND BASEPLATE. INTRA-OPERATIVELY, THE INSERT HAD LOCKED INTO THE BASEPLATE. DISCOVERY WAS MADE POST-OP WHEN THE JR ASSOCIATE WAS TRYING TO ENTER THE CASE USAGE. THE PATIENT WAS REVISED THE NEXT DAY TO IMPLANT A RESTORIS MCK INSERT. JR ASSOCIATE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022232 TRIATHLON PKR INSERT X3 NO 5 RM/LL -8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH XR67RD 07613327015669

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H