BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø40/F

    MDR report key: 14839490 · Received June 28, 2022

    Report

    Report Number
    3005180920-2022-00489
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 30, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812262
    PMA / PMN Number
    K122641
    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 2102165: 40 ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-MAR-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 26 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER COMPONENT REVISED: BALL HEADS: MECTACER 01.29.215 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 (K112115) LOT. 2107509: 60 ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2021. EXPIRATION DATE: 2026-SEP-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 30 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS 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
    736064 LINER: MPACT FLAT PE HC LINER Ø40/F HIP LINER PE LZO MEDACTA INTERNATIONAL SA 01.32.4048HCT 2102165 07630030812262

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention