BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G

    MDR report key: 17255160 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00482
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2243274: 36 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2027-DEC-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883930 LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G HIP FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3652HCT 2243274 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention