BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL DIAMETER 52 TWO-HOLES

    MDR report key: 12238522 · Received July 28, 2021

    Report

    Report Number
    3005180920-2021-00640
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    July 13, 2021
    Report Date
    July 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    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 20 JULY 2021: LOT 1910257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MARCH-2020. EXPIRATION DATE: 2025-MARCH-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO CUP INSTABILITY AND THE CAUSE OF THE CUP INSTABILITY IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO CUP LOOSENING DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138733 CUP: MPACT ACETABULAR SHELL DIAMETER 52 TWO-HOLES ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.152DH 1910257 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention