BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 23529256 · Received November 11, 2025

    Report

    Report Number
    0002249697-2025-01315
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 11, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327315974
    PMA / PMN Number
    K250989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME 28MM STD LFIT V40 HEAD; CAT# 6260-9-128; LOT# 17893356. DEVICE NAME MODULAR DUAL MOBILITY INSERT; CAT# 626-00-42E; LOT# 30051352. DEVICE NAME UNI ADAPTOR SLEEVE V40 TI; CAT# 6519-T-100; LOT# 29609555. DEVICE NAME 6.5MM LOW PROFILE HEX SCREW 20MM; CAT# 7030-6520; LOT# JRUD. DEVICE NAME DELTA UN.FEM HD 28MM R28 16/18; CAT# 6519-1-028; LOT# 25561652. DEVICE NAME 6.5MM LOW PROFILE HEX SCREW 35MM; CAT#7030-6535; LOT# KDGJ. DEVICE NAME TRIDENTII TRITANIUM MULTI 54E; CAT#709-04-54E; LOT# 29653651A. DEVICE NAME 6.5MM LOW PROFILE HEX SCREW 20MM; CAT# 7030-6520; LOT# MU6E. DEVICE NAME 6.5MM LOW PROFILE HEX SCREW 15MM; CAT# 7030-6515; LOT# MXY. 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 FOLLOWING INFORMATION WAS PROVIDED: RIGHT HIP REVISION, PATIENT PRESENTED WITH AN INFECTED SURGICAL SITE. SURGEON SWAPPED THE LINER, INSERT, AND HEAD, AND ALL OTHER COMPONENTS WERE LEFT IN-SITU AT THIS TIME. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644331 RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH WK6W3J 07613327315974

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H