BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C

    MDR report key: 18516286 · Received January 16, 2024

    Report

    Report Number
    3005180920-2023-01119
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 27, 2023
    Report Date
    January 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 JANUARY 2024LOT 2107067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEPT-2021. EXPIRATION DATE: 2026-JUL-05. 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.ADDITIONAL COMPONENT INVOLVED:BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K1121159) LOT 2107483: 200 ITEMS MANUFACTURED AND RELEASED ON 29-SEPT-2021. EXPIRATION DATE: 2026-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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT WAS OCCURRED WHEN EXERCISING. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726728 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / C HIP ACETABULAR LINER LZO MEDACTA INTERNATIONAL SA 2107067 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention