BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 20147355 · Received September 5, 2024

    Report

    Report Number
    3005180920-2024-00711
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19-AUG-2024. LOT 186946: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2024-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    DURING A RANDOM MDR CHECK CONDUCTED ON OCTOBER 1, 2024, AN ERROR WAS NOTICED. A FOLLOW-UP IS BEING INITIATED TO CORRECT IT. THE K NUMBER (K132879) WAS ERRONEOUSLY INSERTED IN THE DEVICE BLA FIELD INSTEAD OF IN THE PMA/510(K).

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT WITH THE STEM. THE SURGEON REVISED THE HEAD WITH MEDACTA HEAD AN SLEEVE, AND LINER AND CUP WITH COMPETITOR'S DEVICES (THE CUP WAS AT 13 DEGREES SO HE CHANGED IT TO 20). SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042977 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 186946 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention