BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23876933 · Received December 23, 2025

    Report

    Report Number
    3005180920-2025-01329
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 19, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812361
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 22 DECEMBER 2025: SCREWS: MPACT 01.32.6515 CANCELLOUS BONE SCREW FLAT HEAD D 6,5 L (K103721) LOT 2002399:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2020. EXPIRATION DATE: 2025-MAY-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW FLAT HEAD D 6,5 L 20 (K103721) LOT 2002400: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2020. EXPIRATION DATE: 2025-MAY-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 3 DEVICES OF THE SAME LOT INVOLVED IN THIS CASE. ROOT CAUSE: ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INVESTIGATION RESULTS DO NOT INDICATE ANY POTENTIAL MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN LOCATED IN THE PELVIC REGION AND THE CAUSE IS UNKNOWN. THE PATIENT BELIEVED THE PAIN WAS DUE TO SCREW PLACEMENT DURING PRIMARY SURGERY. THE SURGEON REMOVED THE 15MM AND 20MM SCREWS IMPLANTED DURING THE PRIMARY. THE SURGEON ALSO REVISED THE 36MM BIOLOX HEAD TO A 28MM BIOLOX HEAD, REVISED THE FLAT D 36 LINER TO A D 28 DOUBLE MOBILITY LINER, AND IMPLANTED A DM CONVERTER AND BIOLOX OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477161 MPACT ACETABULAR SYSTEM CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 15 LPH MEDACTA INTERNATIONAL SA 01.32.6515 2002399 07630030812361

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention