BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 17396951 · Received July 26, 2023

    Report

    Report Number
    3005180920-2023-00571
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    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 11-JUL-2023. LOT 2242559: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-22. 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 5 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654076 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 HIP ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 2242559 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention