BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO FLAT PE HC LINER 36 / E

    MDR report key: 12432603 · Received September 7, 2021

    Report

    Report Number
    3005180920-2021-00715
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807671
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 AUGUST 2021: LOT 1908362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-NOV-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 AUGUST 2021: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 1905651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2019. EXPIRATION DATE: 2024-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331267 VERSAFITCUP CC TRIO FLAT PE HC LINER 36 / E HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.26.3644HCT 1908362 07630030807671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention