BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    MDR report key: 25077221 · Received May 5, 2026

    Report

    Report Number
    3005180920-2026-00395
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630542703928
    PMA / PMN Number
    K241767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 22 APRIL 2026: LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT: 2338168: LOT: 2338168: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-JAN-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT: 2525181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2025. EXPIRATION DATE: 2030-SEP-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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 HAD INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 28/DMC LINER TO A SAME SIZE LINER AND REVISED THE 28MM BIOLOX HEAD L TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412513 VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS DOUBLE MOBILITY HC LINER Ø28/DMC LZO MEDACTA INTERNATIONAL SA 01.26.2846MHC 2338168 07630542703928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention