BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 36MM ID

    MDR report key: 10378312 · Received August 7, 2020

    Report

    Report Number
    0002249697-2020-01626
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 7, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327039559
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: TI SLEEVE FOR ALUMINA HEAD; CAT # 17-0000E; LOT # X08L3N; DELTA C-TAPER HEAD 36MM +5; CAT # 18-3605; LOT # 60666204. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. A 36 MM 'H' TRIDENT X3 0° POLY INSERT, V-40/C-TAPER ADAPTER SLEEVE, AND 36 +5 MM BIOLOX DELTA CERAMIC C-TAPER HEAD WERE REVISED TO A 44 MM 'H' TRIDENT X3 0° POLY INSERT, +4 MM UNIVERSAL V40 TAPER ADAPTER SLEEVE, AND A 44 MM BIOLOX DELTA ANATOMIC UNIVERSAL TAPER HEAD. "PATIENT HAS A CHRONIC INFECTION. LOW-ACTIVITY LEVEL, SEVERE BONE LOSS, COMPONENTS WERE EXCHANGED TO BEST TREAT THE INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843223 TRIDENT 0 X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 623-00-36H YK57DH 07613327039559

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R