BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 40/F

    MDR report key: 10984789 · Received December 10, 2020

    Report

    Report Number
    3005180920-2020-00890
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    November 14, 2020
    Report Date
    December 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812262
    PMA / PMN Number
    K122641
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 NOVEMBER 2020. LOT 2001309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2020. EXPIRATION DATE: 2025-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN HE EVENT. BALL HEADS: MECTACER 01.29.214 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L + 4 (K112115) BATCH REVIEW PERFORMED ON 18 NOVEMBER 2020. LOT 2001878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2020. EXPIRATION DATE: 2025-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    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 12 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452733 LINER: MPACT FLAT PE HC LINER 40/F LINER FLAT LZO MEDACTA INTERNATIONAL SA 01.32.4048HCT 07630030812262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention