BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 12983264 · Received December 13, 2021

    Report

    Report Number
    3005180920-2021-00974
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23.NOV.2021: LOT 2101777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-03-2021. EXPIRATION DATE: 2026-03-03. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 23.NOV.2021: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2100272. LOT 2100272: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-04-2021. EXPIRATION DATE: 2026-04-19. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887517 LINER: MPACT FLAT PE HC LINER Ø36/F FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2101777 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention