BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 20939131 · Received December 16, 2024

    Report

    Report Number
    3005180920-2024-01062
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    November 28, 2024
    Report Date
    January 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: DURING THE ANALYSIS IT IS EVALUATED THE EXPLANTED STEM, TOGETHER WITH THE CUP, LINER AND FEMORAL HEAD. ON THE STEM BODY SOME SPOTS OF OPAQUE WHITE FILM ARE VISIBLE ON DISTAL PART OF THE STEM BODY. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. LOOKING AT THE PE LINER IT SEEMS THAT ITS SHAPE IS SLIGHTLY ECCENTRIC DUE TO 15 YEARS OF WEAR EVEN IF ITS INTERNAL SURFACE SEEMS TO BE INTACT WITHOUT ANY PARTICULAR SCRATCHES. ONLY ONE SPOT OF SCRATCH IS VISIBLE APPROXIMATELY IN THE MIDDLE OF THE LINER, PROBABLY DUE TO THE NORMAL WEAR RATE. THE SURFACE OF FEMORAL HEAD IS SLIGHTLY SCRATCHED PROBABLY DUE TO REVISION SURGERY. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02-DEC-2024: LOT 091187: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2009. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE REVISED BATCH REVIEW PERFORMED ON 02-DEC-2024: LOT 091422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2009. EXPIRATION DATE: 2014-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: 15 YEARS AFTER PRIMARY CEMENTLESS THA, THE STEM APPEARS PROXIMALLY LOOSE AND IT IS PROBABLY PAINFUL, SO A REVISION IS UNDERTAKEN. WE CAN ALSO OBSERVE SOME VISIBLE WEAR OF THE PE INSERT, ALTHOUGH THERE IS NO MACROSCOPIC EVIDENCE OF OSTEOLYTIC PROCESSES IN THE FEMUR - THE LOOSENING OF THE STEMS SEEMS MORE LIKELY DUE TO PROGRESSIVE DISTALIZATION OF THE LOAD, BUT NO RADIOGRAPHIC SEQUENCE WAS SUPPLIED, SO WE CANNOT DETERMINE THIS PATTERN.

    Description of Event or Problem · 0

    AT ABOUT 15 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF CEMENTLESS STEM LOOSENING. DURING REVISION IT WAS NOTICED ECCENTRIC LINER WEAR. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY, ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355028 VERSAFITCUP CC TRIO ACETABULAR SYSTEM FLAT PE HC LINER Ø 28 / C LZO MEDACTA INTERNATIONAL SA 01.26.2839HCT 091187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention