BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

    MDR report key: 19517427 · Received June 12, 2024

    Report

    Report Number
    3005180920-2024-00393
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860997
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MAY 2024 LOT 1905348: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2019. EXPIRATION DATE: 2024-10-28. 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.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS AND 4 MONTHS POST PRIMARY REVISION SURGERY FOR MPACT DM LOOSENING. ACETABULAR COMPONENTS AND HEAD WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373185 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56 HIP DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1905348 07630030860997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention