BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    MDR report key: 23244044 · Received October 8, 2025

    Report

    Report Number
    3005180920-2025-00979
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K241767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-SEP-2025: LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER Ø28/DMC (K241767) LOT 2338169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 22-NOV-2028. 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. BALL HEADS: MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT 2510685: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2025. EXPIRATION DATE: 15-APR-2030. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASH OUT AND REVISED THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609994 VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS MPACT DM DOUBLE MOBILITY HC LINER Ø28/DMC LZO MEDACTA INTERNATIONAL SA 01.26.2846MHC 2338169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention