BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

    MDR report key: 13515072 · Received February 11, 2022

    Report

    Report Number
    3005180920-2022-00096
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    January 17, 2022
    Report Date
    February 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2101759: 135 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 125 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2022. VERSAFITCUP CC TRIO 01.26.45.0046 ACETABULAR SHELL CC TRIO Ø 48 (K103352); LOT 2101345: 150 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 106 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SMS SOLID 01.36.046 SMS SOLID STEM STD SIZE 6 (K181693); LOT 2000852: 20 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: (B)(6) 2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 17 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115); LOT 2012911: 400 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: (B)(6) 2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 314 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER 3 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76387 VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C FLAT PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.26.3239HCT 2101759 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention