BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 NO-HOLE

    MDR report key: 11938617 · Received June 4, 2021

    Report

    Report Number
    3005180920-2021-00469
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 4, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810787
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MAY 2021: LOT 1902284: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2019. EXPIRATION DATE: 2024-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING GROIN PAIN, WHICH WAS CAUSED BY OVER ANTEVERTED CUP POSITION. THE CAUSE OF THE ANTEVERTED CUP IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833518 CUP: MPACT ACETABULAR SHELL 50 NO-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.150SH 1902284 07630030810787

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention