BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVISION

    MDR report key: 22847982 · Received August 20, 2025

    Report

    Report Number
    3008021110-2025-00112
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 15, 2025
    Report Date
    June 3, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWY
    UDI-DI
    08033390003865
    PMA / PMN Number
    K151739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZATION RECORDS OF THE DEVICES INVOLVED WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING DEVIATION DETECTED ON THE 28 REVISION MOD. STEMS Ø16MM PRODUCT CODE 381215010, RELEASED WITH LOT 2305109, STER. (B)(4). - NO PRE-EXISTING DEVIATION DETECTED ON THE 9 DELTA-ONE-TT ACETAB.CUPS Ø56MM PRODUCT CODE 554914560 RELEASED WITH LOT 2223058, STER. (B)(4). - NO PRE-EXISTING DEVIATION DETECTED ON THE 60 DELTA ANGLED SPACERS 20°# L+5 PRODUCT CODE 588615520, RELEASED WITH LOT 2213348, STER. (B)(4). WE WILL SUBMIT A FINAL REPORT UPON THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2025. THE PREVIOUS SURGERY TOOK PLACE IN (B)(6) 2023 (EXACT DATE NOT KNOWN). ACCORDING TO THE INFORMATION RECEIVED, THE FOLLOWING DEVICES WERE EXPLANTED: - REVISION MOD. STEM Ø16MM PRODUCT CODE 381215010, LOT 2305109, STER. (B)(4). - DELTA-ONE-TT ACETAB.CUP Ø56MM PRODUCT CODE 554914560, LOT 2223058, STER. (B)(4). - DELTA ANGLED SPACER 20°# L+5 PRODUCT CODE 588615520, LOT 2213348, STER. (B)(4). - FEMORAL HEAD (PRODUCT DETAILS ARE UNKNOWN). THIS EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154831 REVISION UNCEMENTED STEM DIA=16MM - L=140MM KWY LIMACORPORATE S.P.A. 08033390003865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention