BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 DEG X3 INSERT 36MM ID

    MDR report key: 18444576 · Received January 4, 2024

    Report

    Report Number
    0002249697-2024-00020
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 4, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327039917
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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. 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRIT HEMI CLUSTER HOLE CUP 54MM; CAT # 502-03-54E; LOT # MT6NKH PRIMARY SECUR-FIT PLUS MAX NO 9 13MM; CAT # 6054-0913S; LOT # 748E1W DELTA C-TAPER HEAD 36MM +0; CAT # 18-3600; LOT # 61150102 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. H3 OTHER TEXT : NOT AVAILABLE

    Description of Event or Problem · 0

    PATIENT REPORTED HAVING PAIN IN LEFT HIP AND WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607315 TRIDENT 10 DEG X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 8685T3 07613327039917

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other