BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 10161524 · Received June 17, 2020

    Report

    Report Number
    0002249697-2020-01201
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 17, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327039924
    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: TRITANIUM REVISION ACETABULAR; CAT # 509-02-58F ; LOT # TW60AJ. GAP PLATE SCREWS; CAT # 2080-0025; LOT # ML1MX0. GAP PLATE SCREWS; CAT # 2080-0020; LOT # T22X7D. GAP PLATE SCREWS; CAT # 2080-0035; LOT # 7206EA. GAP PLATE SCREWS; CAT # 2080-0030; LOT # PJ0L4Y. DELTA C-TAPER HEAD 36MM +7.5; CAT # 18-3675; LOT # 62258501. TI SLEEVE FOR ALUMINA HEAD; CAT # 17-0000E; LOT # 331T4M. SIZE 6 ACCOLADE II 132 DEG; CAT # 6720-0635; LOT # 52634701. 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 · 1

    IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION. THE PATIENT'S STEM (IMPLANTED (B)(6) 2015), SLEEVE, FEMORAL HEAD, LINER, SHELL AND SCREWS (IMPLANTED ON (B)(6) 2019, REVISION REPORTED) WERE REVISED AND A SPACER PLACED. REP PROVIDED USAGE SHEETS FROM PRIMARY AND PREVIOUS SURGERIES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625004 TRIDENT 10° X3 INSERT 36MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 623-10-36F 3D03LE 07613327039924

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R