BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56

    MDR report key: 16553137 · Received March 16, 2023

    Report

    Report Number
    3005180920-2023-00157
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 16, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807916
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDIIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 21 MARCH 2023. LINER: VERSAFITCUP CC TRIO 01.26.3648HCT FLAT PE HC LINER Ø 36 / F (K103352) LOT 2009643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2020. EXPIRATION DATE: 2025-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2011679: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: MASTERLOC 01.39.204 CEMENTLESS TI COATED LAT STEM SIZE 4 (K151531) LOT. 2009556: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 05-JAN-2021. EXPIRATION DATE: 2025-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MARCH 2023. LOT 2011634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MARCH-2021. EXPIRATION DATE: 2026-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: FROM THE RECEIVED PHOTOS AND INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE A ROOT CAUSE OF THE EVENT. OTHER DEVICE INVOLVED: STEM: MASTERLOC 01.39.204 CEMENTLESS TI COATED LAT STEM SIZE 4 (K151531).

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828528 CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56 HIP ACETABULAR SHELL CC TRIO NO-HOLE LZO MEDACTA INTERNATIONAL SA 01.26.45.1156 2011634 07630030807916

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention