BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 17773624 · Received September 19, 2023

    Report

    Report Number
    3005180920-2023-00734
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-SEPT-2023. LOT 2001283: 149 ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2020. EXPIRATION DATE: 2025-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 2 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ILIOPSOAS IMPINGEMENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447120 CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES HIP CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 2001283 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention