BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS

    MDR report key: 24711032 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00250
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 27, 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 REVIEW PERFORMED ON 11 MAR 2026. LINER: VERSAFITCUP CC TRIO 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT. 2520044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCT 2025. EXPIRATION DATE: 2030-SEPT -09. 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. LINER: VERSAFITCUP CC TRIO 01.32.3844CF DM CONVERTER E/DMC - TIN COATED (K211891)LOT. 2503248: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JUL 2025. EXPIRATION DATE: 2030-JUL-07. 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. CUP: VERSAFITCUP CC TRIO 01.26.45.0050 VERSAFITCUP METALBACK CC TRIO D 50 MM (K103352) LOT. 2500243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAR 2025. EXPIRATION DATE: 2030-MARCH-03. 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: COCR 01.25.014 COCR BALL HEAD 12/14 D 28 MM SIZE XL (K072857) LOT. 2345673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAR 2024. EXPIRATION DATE: 2029-MAR-07. 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. 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

    REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 DAYS AFTER THE PRIMARY SURGERY DUE TO AN ACUTE JOINT INFECTION OF UNKNOWN ORIGIN.THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773613 VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS DOUBLE MOBILITY HC LINER Ø28/DMC LZO MEDACTA INTERNATIONAL SA 01.26.2846MHC 2520044 07630542703928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention