BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 3D METAL

    MDR report key: 25328462 · Received May 29, 2026

    Report

    Report Number
    3005180920-2026-00476
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812606
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: THE COMPLAINT DESCRIBES AN EARLY REVISION OF A CEMENTLESS THA APPROXIMATELY 8.5 MONTHS AFTER PRIMARY IMPLANTATION DUE TO ACETABULAR CUP LOOSENING, WITH RADIOGRAPHIC RADIOLUCENCY AROUND THE CUP AND A CRANIAL GAP BETWEEN THE ACETABULAR BONE AND SHELL. IN THE CONTEXT OF COXA PROFUNDA WITH A VERY THIN MEDIAL ACETABULAR WALL, THIS FINDING MAY SUGGEST CHALLENGING ACETABULAR ANATOMY WITH REDUCED STRUCTURAL SUPPORT, POTENTIALLY CONTRIBUTING TO SUBOPTIMAL INITIAL SEATING, INSUFFICIENT PRESS-FIT STABILITY, MICROMOTION, AND FAILURE OF SUCCESSFUL OSSEOINTEGRATION. HOWEVER, THE EXACT ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND THERE IS CURRENTLY NO CONFIRMED EVIDENCE OF DEVICE MALFUNCTION OR MANUFACTURING DEFECT. BATCH REVIEW PERFORMED ON 06 MAY 2026 CUP: MPACT 3D METAL 01.38.054DH MPACT 3D METAL SHELL TWO HOLE D 54MM (K171966) LOT 2417821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2024. EXPIRATION DATE: 11-JUL-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. ROOT CAUSE: ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE EVENT MAY BE RELATED TO CASE-SPECIFIC CLINICAL AND ANATOMICAL FACTORS, INCLUDING COXA PROFUNDA WITH A VERY THIN MEDIAL ACETABULAR WALL, WHICH MAY HAVE REDUCED ACETABULAR STRUCTURAL SUPPORT AND CONTRIBUTED TO SUBOPTIMAL INITIAL SEATING, INSUFFICIENT PRESS-FIT STABILITY, MICROMOTION, AND UNSUCCESSFUL OSSEOINTEGRATION OF THE CEMENTLESS CUP. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIALLY RELATED MANUFACTURING ANOMALY.

    Description of Event or Problem · 0

    AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING MILD PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR INFECTION INDICATED. AFTER AN ORTHOPEDIC SURGEON OBSERVATION, THE CUP LOOSENING HAD INCREASED. THE SURGEON REVISED THE AMISTEM-P COLLARED SIZE 3 TO A QUADRA-P CEMENTED SIZE 2, THE 36MM BIOLOX HEAD S TO AN HEAD L, THE HOODED PE HC LINER D 36/E TO A D 36/F, AND THE MPACT 3D METAL SHELL TWO HOLE D 54MM TO A MULTI HOLE D 60MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380180 MPACT 3D METAL MPACT 3D METAL SHELL TWO HOLE Ø54MM LPH MEDACTA INTERNATIONAL SA 01.38.054DH 2417821 07630030812606

    Patients

    Seq Age Sex Outcome Treatment
    1