BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 23837280 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01219
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630345798763
    PMA / PMN Number
    K230011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2025. CUP: MPACT 01.32.154DHT ACETABULAR SHELL D 54 TWO-HOLES T (K230011). LOT. 2505208: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MAY 2025. EXPIRATION DATE: 22 APRIL 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. CLINICAL EVALUATION, A FEW WEEKS AFTER THE PRIMARY CEMENTLESS THA, THE ACETABULAR CUP TILTED AND REQUIRED REPLACEMENT WITH A MODEL EQUIPPED WITH BONE SCREWS. THE CAUSE OF THIS EVENT IS MOST LIKELY RELATED TO INSUFFICIENT PRIMARY STABILITY, POSSIBLY DUE TO INADEQUATE PRESS-FIT OR POOR BONE QUALITY. ANOTHER POSSIBLE EXPLANATION IS AN ACCIDENTAL, QUASI-TRAUMATIC EVENT (NOT REPORTED), POTENTIALLY OCCURRING DURING REHABILITATION, WHICH MAY HAVE SUBJECTED THE IMPLANT-BONE INTERFACE TO EXCESSIVE EARLY FORCES BEFORE SECONDARY FIXATION COULD TAKE PLACE. THERE IS NO INDICATION TO SUSPECT A FAULTY IMPLANT. ROOT CAUSE: ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY CONFIRMED, THE TILTING OF THE ACETABULAR CUP WAS LIKELY RELATED TO INSUFFICIENT PRIMARY STABILITY AND, CONSEQUENTLY, TO LOW RESISTANCE TO FORCES ACTING DURING THE EARLY POSTOPERATIVE STAGES.

    Description of Event or Problem · 0

    TWO MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT RETURNED DUE TO PAIN. THE SURGEON DISCOVERED THAT THE ACETABULAR CUP HAD SPUN AND BECOME VERTICAL. A MULTI-HOLE CUP WAS IMPLANTED WITH TWO 25 MM SCREWS, AND THE HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617685 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø54 TWO-HOLES T LPH MEDACTA INTERNATIONAL SA 01.32.154DHT 2505208 07630345798763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention