BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR SYSTEM IMPLANTS

    MDR report key: 23477195 · Received November 5, 2025

    Report

    Report Number
    3005180920-2025-01058
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 OCTOBER 2025. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT2509643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON04-JUL-2025. EXPIRATION DATE: 12-JUN-2030. 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. CUP: MPACT 01.32.148DHT ACETABULAR SHELL Ø48 TWO-HOLES T (K230011) LOT2508415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON09-JUN-2025. EXPIRATION DATE: 25-MAY-2030. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE. A POSSIBLE REASON COULD BE RELATED TO THE PRESENCE OF LIQUID/TISSUE INSIDE THE SHELL OR TO AN IMPROPER ALIGNMENT OF THE TWO DEVICES DURING THE IMPACTION.

    Description of Event or Problem · 0

    THE LINER COULD NOT BE INSERTED INTO THE CUP. THERE WAS NO LIFTING OF THE SCREWS OR THE CENTRAL PLUG. A NEW LINER (FROM A DIFFERENT LOT) WAS USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. 30 MIN DELAY TO REMOVE THE LINER AND IMPLANT A NEW ONE (TOT TIME 2 HOURS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491516 MPACT ACETABULAR SYSTEM IMPLANTS FLAT PE HC LINER Ø32/D LPH MEDACTA INTERNATIONAL SA 01.32.3241HCT 2509643 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other