BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 16322503 · Received February 8, 2023

    Report

    Report Number
    3005180920-2023-00042
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 8, 2023
    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 18 JANUARY 2023: LOT 186971: 108 ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2018. EXPIRATION DATE: 2023-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 18 JANUARY 2023 ON BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2211903 LOT 2211903: 200 ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2022. EXPIRATION DATE: 2027-07-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 160 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN 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. AT ABOUT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314002 LINER: MPACT FLAT PE HC LINER Ø36/F HIP HIGH CROSS POLYETHYLENE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 186971 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention