BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/G

    MDR report key: 9826672 · Received March 12, 2020

    Report

    Report Number
    3005180920-2020-00150
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861017
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 176967: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2018. EXPIRATION DATE: 2023-01-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 LOT. 1901941. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2020: LOT 1901941: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 18 DAYS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290548 LINER: MPACT FLAT PE HC LINER Ø36/G FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.160MB 176967 07630030861017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention