BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    MDR report key: 16813625 · Received April 26, 2023

    Report

    Report Number
    3005180920-2023-00279
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810800
    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 29 MARCH 2023: LOT 2011719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2021. EXPIRATION DATE: 2026-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT 25 DAYS FROM PRIMARY SURGERY DUE TO CUP LOOSENING. ACETABULAR COMPONENTS WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791517 CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE HIP ACETABULAR SHELL MULTI-HOLE CEMENTLESS LPH MEDACTA INTERNATIONAL SA 01.32.152MH 2011719 07630030810800

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention