BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

    MDR report key: 17413517 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00596
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807886
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JULY 2023: LOT: 2008836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2020. EXPIRATION DATE: 2025-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 18 JULY 2023 ON LINER: MECTACER 01.29.410 CERAMIC LINER Ø 32 / E LOT. 2010646. LOT: 2010646: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-02-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ITEM NOT REGISTERED IN US. BATCH REVIEW PERFORMED ON 18 JULY 2023 ON STEM: AMISTEM P 01.18.403 AMISTEM-P STD STEM SIZE 3 (K173794) LOT. 2010548. LOT: 2010548: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JAN-2021. EXPIRATION DATE: 2025-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 18 JULY 2023 ON BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT. 2010628. LOT: 2010628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 2 YEARS FROM PRIMARY FOR HIP INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337217 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 HIP ACETABULA SHELL CEMENTLESS LZO MEDACTA INTERNATIONAL SA 2008836 07630030807886

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention