BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 24276569 · Received February 6, 2026

    Report

    Report Number
    3005180920-2026-00079
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 6, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630345798664
    PMA / PMN Number
    K230011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 JANUARY 2026. CUP: MPACT 01.32.144MHT ACETABULAR SHELL D 44 MULTI-HOLE T (K230011) LOT 2418538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2024. EXPIRATION DATE: 28-NOV-2029. 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 PRIMARY CEMENTLESS THA, THE FEMALE PATIENT SUFFERS ACETABULAR MOBILIZATION AND NEEDS REPLACING THE CUP. THE PATIENT IS SMALL AND HER PELVIS RATHER SHALOW, WHICH MAY HAVE MADE DIFFICULT ACHIEVING A GOOD PRESS-FIT OF THE CUP, THAT SEEMS TO BE NOT TOUCHING THE BONE AT THE SUPERIOR EDGE. IN THESE CONDITIONS, DURING REHABILITATION, AN EXCESSIVE STRESS MAY HAVE TRIGGERED EARLY MOBILIZATION, IN SPITE OF THE SCREW THAT WAS IMPLANTED TO SUPPORT STABILITY. NO REASON TO SUSPECT THAT A DEFECTIVE DEVICE ORIGINATED THIS ADVERSE EVENT. ROOT CAUSE:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. IN THIS CASE, THE PATIENT¿S SMALL BUILD AND THE SHALLOW DEPTH OF THE PELVIS MAY HAVE MADE IT DIFFICULT TO ACHIEVE A GOOD PRESS-FIT OF THE CUP; THERE APPEARS TO BE NOT TOUCHING THE BONE AT THE SUPERIOR EDGE, WHICH, COMBINED WITH EXCESSIVE STRESS DURING REHABILITATION, MAY HAVE LED TO EARLY MOBILIZATION DESPITE THE USE OF A STABILIZING SCREW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, DURING POSTOPERATIVE FOLLOW-UP, THE PATIENT PRESENTED WITH PAIN, AND LOOSENING OF THE ACETABULAR CUP WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344057 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø44 MULTI-HOLE T LPH MEDACTA INTERNATIONAL SA 01.32.144MHT 2418538 07630345798664

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention