BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES

    MDR report key: 19267219 · Received May 8, 2024

    Report

    Report Number
    3005180920-2024-00279
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 8, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    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 (B)(6) 2024. LOT 2210023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 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 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757804 CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 2210023 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention