BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA LINERS & ACCESSORIES

    MDR report key: 22922803 · Received August 29, 2025

    Report

    Report Number
    3008021110-2025-00110
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 29, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    UDI-DI
    08033390136105
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE FOLLOWING LOT NUMBERS: - LOT NUMBER 2333067, STERILIZATION (B)(4). - LOT NUMBER 24AT0A7, STERILIZATION (B)(4). - LOT NUMBER 2509960, STERILIZATION (B)(4). THE MANUFACTURER WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISLOCATION. THE FOLLOWING COMPONENTS WERE REMOVED: - DELTA TT PRO D.52MM MEDIUM+ (PART CODE 5553.14.523, LOT NUMBER 2333067, STERILIZATION (B)(4)). - DELTA NEUTR. LINER D.36MM #M+ (PART CODE 5885.54.259, LOT NUMBER 24AT0A7, STERILIZATION (B)(4)). - BONE SCREW Ø6,5 H.30MM (PART CODE 8420.15.030, LOT NUMBER 2509960, STERILIZATION (B)(4)). THESE COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: - DELTA TT CUP D.54MM (PART CODE 5552.15.540, LOT NUMBER 2304688, STERILIZATION (B)(4)). - DELTA MOBILE LINER (PART CODE 5566.50.420, LOT NUMBER 20AT0Y8, STERILIZATION (B)(4)). - BONE SCREW DIA=6.5MM H=25MM (PART CODE 8420.15.020, LOT NUMBER 2411118, STERILIZATION (B)(4)). - BONE SCREW DIA=6.5MM H=35MM (PART CODE 8420.15.040, LOT NUMBER 2201892, STERILIZATION (B)(4)). - DELTA CUP DUAL MOBILITY LINER #LARGE (PART CODE 5885.09.042, LOT NUMBER 2017046, STERILIZATION (B)(4)). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6)1953. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222583 DELTA LINERS & ACCESSORIES NEUTRAL LIMAVIT LINER I.D. 36MM, SIZE MEDIUM+ LPH LIMACORPORATE S.P.A. 5885.54.259 24AT0A7 08033390136105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention