BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 7971085 · Received October 16, 2018

    Report

    Report Number
    0002249697-2018-03397
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    April 9, 2018
    Report Date
    October 16, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327039535
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER 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: TRITANIUM REVISION ACETABULAR; CAT#509-02-58F; LOT#8W7JV8. DELTA C-TAPER HEAD 36MM +0; CAT#18-3600; LOT#60366602. SECUR-FIT MAX 132 HIP STEM #12; CAT#6051-1240S; LOT#MNL277. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT WAS RE-IMPLANTED ON (B)(6) 2018. AFTER TWO WEEKS, PATIENT RETURNED WITH AN INFECTED HEMATOMA AND CONTINUED PERIPROSTHETIC JOINT INFECTION. PATIENT THEN UNDERWENT ONE-STAGE EXCHANGE OF THE RIGHT HIP WITH ALL IMPLANTS REVISED (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811800 TRIDENT 0° X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 3567VW 07613327039535

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R