BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC 36/F

    MDR report key: 12058272 · Received June 24, 2021

    Report

    Report Number
    3005180920-2021-00512
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 2 JUNE 2021: LOT 1910290: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2024-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD. TWO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 2 JUNE 2021: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 2006693: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2020. EXPIRATION DATE: 2025-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960561 LINER: MPACT FLAT PE HC 36/F CEMENTLESS ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 1910290 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention