BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CUP ACCESSORIES

    MDR report key: 23243964 · Received October 8, 2025

    Report

    Report Number
    3008021110-2025-00136
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    April 29, 2025
    Report Date
    October 8, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALIES WERE DETECTED BY THE CHECK OF THE STERILIZATION CHARTS OF: - THE 6 DELTA-REVISION ACET.CUPS Ø50MM RELEASED WITH CODE 553321050 LOT 2003735 STER (B)(4). - THE 50 DELTA PROTR.LINERS ØINT 36MM #L RELEASED WITH CODE 588651260 LOT 2424476 STER (B)(4). - THE 200 BONE SCREWS Ø6,5 H.30MM RELEASED WITH CODE 842015030 LOT 2417494 STER (B)(4). - THE 190 BONE SCREWS Ø6,5 H.25MM RELEASED WITH CODE 842015020 LOT 2415177 STER (B)(4). - ON THE 200 BONE SCREWS Ø6,5 H.25MM RELEASED WITH CODE 842015020 LOT 2419828 STER (B)(4). THIS IS THE FIRST AND ONLY COMPLAINT DUE TO INFECTION RECORDED ON THE LISTED STER. NUMBERS. A FINAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATIONS.

    Description of Event or Problem · 0

    LEFT HIP REVISION SURGERY DUE TO PERIPROSTHETIC JOINT INFECTION- REDNESS AROUND THE SCAR. REVISION DATE IS (B)(6) 2025. REMOVAL OF EXTENSIVE INFLAMMATORY GRANULATION TISSUE AND NECROTIC TISSUES AROUND THE ACETABULUM, HIP AND RIGHT THIGH AND IMPLANTATION OF A GARAMYCIN SPONGE AND CEMENT FILLING. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024. DEVICES INVOLVED: - DELTA-REVISION ACET.CUP Ø50MM CODE 553321050 LOT 2003735 STER (B)(4). - DELTA PROTR.LINER ØINT 36MM #L CODE 588651260 LOT 2424476 STER (B)(4). - BONE SCREW Ø6,5 H.30MM CODE 842015030 LOT 2417494 STER (B)(4). - BONE SCREW Ø6,5 H.25MM CODE 842015020 LOT 2415177 STER (B)(4). - BONE SCREW Ø6,5 H.25MM CODE 842015020 LOT 2419828 STER (B)(4). PATIENT DETAILS: FEMALE, BORN IN 1950, 155 CM, 98 KG, BMI 40.8, RETIRED. PREVIOUS HIP TREATMENTS OR SURGERIES: (B)(6) 2022 THA ON THE LEFT SIDE. (B)(6) 2021 THA ON THE RIGHT SIDE. THIS EVENT OCCURRED IN POLAND AND ONLY THE LINER AND SCREWS ARE CLEARED IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586863 DELTA CUP ACCESSORIES PROTRUDED LINER LPH LIMACORPORATE S.P.A. 5886.51.260 2424476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention