BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 18482453 · Received January 10, 2024

    Report

    Report Number
    3005180920-2023-01092
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 13, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-DEC-2023. LOT 2201631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-02-22. 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 THE REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TUMOR. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO LINER WEAR. THE SURGEON REVISED THE LINER, HEAD AND OPTION SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142986 LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 2201631 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention