BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

    MDR report key: 13584649 · Received February 23, 2022

    Report

    Report Number
    3005180920-2022-00140
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 23, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810855
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JANUARY 2022. LOT 2100137: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MARCH-2021. EXPIRATION DATE: 2026-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JANUARY 2022. LOT 2100137: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MARCH-2021. EXPIRATION DATE: 2026-03-10. 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 · 0

    AT 1 MONTH AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    AT 1 MONTH AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673991 CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.156DH 2100137 07630030810855

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention