BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C

    MDR report key: 14641193 · Received June 9, 2022

    Report

    Report Number
    3005180920-2022-00431
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 9, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2022. LOT 2107067: 90 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 71 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT INVOLVED: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT 2109337: 200 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE HEAD AND THE LINER WERE REVISED 19 DAYS AFTER PRIMARY DUE TO A SUPERFICIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421496 LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C HIP ACETABULAR LINER PE LZO MEDACTA INTERNATIONAL SA 01.26.3239HCT 2107067 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention