BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52

    MDR report key: 17144072 · Received June 16, 2023

    Report

    Report Number
    3005180920-2023-00437
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    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 06-JUN-2023. LOT 2001266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2020. EXPIRATION DATE: 2025-04-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON OBSERVED THAT THE PATIENT HAD A MALPOSITIONED CUP AND THE CAUSE OF THE MALPOSITIONING IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494465 CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 HIP DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152MB 2001266 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention