BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT 3DMETAL ACETABULAR SHELL 52 TWO-HOLE

    MDR report key: 12224557 · Received July 26, 2021

    Report

    Report Number
    3005180920-2021-00610
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812590
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2021: LOT 2010338: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2020. EXPIRATION DATE: 2025-11-24. 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 THE CUP NOT GROWING IN. THE CAUSE OF THE CUP NOT GROWING IN IS UNKNOWN. 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121510 MPACT 3DMETAL ACETABULAR SHELL 52 TWO-HOLE HIP UNCEMENTED SHELL LPH MEDACTA INTERNATIONAL SA 2010338 07630030812590

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention