BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 32H

    MDR report key: 19838979 · Received July 26, 2024

    Report

    Report Number
    0002249697-2024-01033
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    August 1, 2023
    Report Date
    July 26, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    UDI-DI
    07613327025569
    PMA / PMN Number
    K233498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DELTA C-TAPER HEAD 32MM +5; CAT #18-3205 ; LOT 79477001. PROXIMAL FEM COMP STD; CAT # 64951001; LOT NH63Y. TI SLEEVE FOR ALUMINA HEAD; CAT # 17-0000E; LOT 8W30E9. TRIDENTII TRITANIUM MULTI 64H; CAT # 709-04-64H; LOT 73660201A. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING AN TRIDENT LINER 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 OR STERILE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 IN ACCORDANCE WITH APPLICABLE ISO STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS AND THE REVISION OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY LEFT THA OUT OF CORS SCOPE. ON (B)(6) 2022, THE PATIENT HAS A PERIPROSTHETIC JOINT INFECTION AND IS ENTERED INTO CORS WITH A PROXIMAL FEMORAL REPLACEMENT. THE PATIENT DEVELOPED AGAIN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT DEVELOPS PJI AGAIN AND A REVISION IS PERFORMED, WITH CONSTRAINED LINER, HEAD (AND TAPER SLEEVE), AND PROXIMAL GMRS COMPONENTS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614467 TRIDENT 0 DEG CONSTRAINED INSERT 32H PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER KWZ STRYKER ORTHOPAEDICS-MAHWAH LL7XWN 07613327025569

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H