BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 21321318 · Received February 6, 2025

    Report

    Report Number
    3005180920-2025-00031
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030810862
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2025. LOT: 2305777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 2028-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED; BATCH REVIEW PERFORMED ON 06 FEBRUARY 2025. STEM: QUADRA-P 01.12.143 QUADRA-P LAT STEM SIZE 3 (K181254) LOT: 2249410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUNE-2023. EXPIRATION DATE: 2028-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIR DIRECTOR. A REVISION SURGERY WAS PERFORMED ONE YEAR AFTER THE PRIMARY TOTAL HIP ARTHROPLASTY (THA) DUE TO INTRAPELVIC MIGRATION OF THE ACETABULAR CUP. THE AVAILABLE X-RAY IMAGES CLEARLY CONFIRM THE INTRAPELVIC MIGRATION OF THE ACETABULAR COMPONENT, WHICH ALSO APPEARS ROTATED. ADDITIONALLY, THE FEMORAL STEM APPEARS LOOSE WITHIN THE FEMUR. AS THE POSTOPERATIVE X-RAY IS UNAVAILABLE, WE CANNOT ASSESS THE INITIAL POSITION OF THE PROSTHETIC COMPONENTS. HOWEVER, BONE QUALITY LIKELY PLAYED A ROLE, AS IT IS REPORTED TO BE POOR. NO HISTORY OF TRAUMA HAS BEEN DOCUMENTED. GIVEN THE AVAILABLE INFORMATION, WE CANNOT DRAW DEFINITIVE CONCLUSIONS, BUT THIS FAILURE DOES NOT APPEAR TO BE DUE TO A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO THE CUP TEARING THROUGH THE ACETABULUM DUE TO POOR BONE. THE SURGEON REVISED THE STEM AND HEAD WITH MEDACTA COMPONENTS AND REVISED THE CUP AND LINER TO COMPETITOR COMPONENTS AT ABOUT 1 YEAR AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. FROM THE ANALYSIS OF THE X-RAYS, IT WAS DISCOVERED ALSO THE LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732574 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø56 MULTI HOLES LZO MEDACTA INTERNATIONAL SA 01.32.156MH 2305777 07630030810862

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention