BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 6632538 · Received June 9, 2017

    Report

    Report Number
    0002249697-2017-01817
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 31, 2015
    Report Date
    June 9, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRITANIUM REVISION ACETABULAR; CAT# 509-02-58F; LOT# JK4PT0. DELTA C-TAPER HEAD 36MM +0; CAT# 18-3600; LOT# 44288901. REST HA -5 RED NK 155MM STRT STM 9X13MM; CAT# S-2651-0913; LOT# MNM874. GAP PLATE SCREWS; CAT# 2080-0030; LOT# MNHL8E. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED.

    Description of Event or Problem · 1

    IT WAS REPORTED, POSTOPERATIVE DIAGNOSIS: INFECTED TOTAL HIP ARTHROPLASTY. LEFT HIP RESECTION ARTHROPLASTY WITH INSERTION OF CEMENT SPACER. THEN REIMPLANTATION ON (B)(6) 2015. NEW REINFECTION AND RESECTION OF ALL COMPONENTS IN (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410987 TRIDENT 0° X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH HJ137W

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R