BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025

    MDR report key: 21890169 · Received April 23, 2025

    Report

    Report Number
    0002249697-2025-00431
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 23, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540641090
    PMA / PMN Number
    K013106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MOD CON DIST STEM 18 X 155 MM; CAT# 6276-7-018; LOT# CAX102650A, V40 COCR LFIT HEAD 36MM +5 OFFSET; CAT# 6260-9-236; LOT# DP4RH4. 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

    SURGEON ADVISED IN THE SCRUB BAY THAT THE 'REVISION FROM THURSDAY WAS INFECTED'. WE HAD TAKEN SWABS DURING HIS REVISION SURGERY AND THEY HAD GROWN CULTURES. DOCTOR TELLS ME WE ARE NO LONGER DOING THIS PATIENTS SUBSEQUENT REVISION HIP REPLACEMENT. THE PLAN IS NOW TO MANAGE WITH ANTIBIOTICS AND NOT REVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256898 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 24891652 04546540641090

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other