BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10 DEG X3 INSERT 36MM ID

    MDR report key: 15319607 · Received August 30, 2022

    Report

    Report Number
    0002249697-2022-01267
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    November 11, 2021
    Report Date
    August 30, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327339611
    PMA / PMN Number
    K182468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    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 OTHER 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#709-04-52E; TRIDENTII TRITANIUM MULTI 52E; LOT# 85003301A, CAT# 18-3605; DELTA C-TAPER HEAD 36MM +5; LOT# 86414001, CAT# 17-0000E; TI SLEEVE FOR ALUMINA HEAD; LOT# HV22T7. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY THA OUTSIDE OF CORS SCOPE. ON (B)(6), 2021 PATIENT UNDERWENT A LEFT THA REVISION FOR IMPINGEMENT. THE PATIENT LATER DEVELOPED AN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6), 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148579 TRIDENT 10 DEG X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 723-10-36E NM760N 07613327339611

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R