BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12364717 · Received August 25, 2021

    Report

    Report Number
    3005180920-2021-00675
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 25, 2021
    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 · 1

    BATCH REVIEW PERFORMED ON 02 AUG 2021: LOT 2001444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2020. EXPIRATION DATE: 2025-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 02 AUG 2021: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 2006686 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2020. EXPIRATION DATE: 2025-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION (PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 4 MONTHS AND A HALF AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264566 VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER DIAM 32 / C HIP LINER FLAT LZO MEDACTA INTERNATIONAL SA 01.26.3239HCT 2001444 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention