BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC 36/E

    MDR report key: 11776172 · Received May 5, 2021

    Report

    Report Number
    3005180920-2021-00349
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    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 12 APRIL 2021: LOT 2009609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-11. 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. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 12 APRIL 2021: BALL HEADS: COCR 01.25.032 COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5 (K080885) LOT 2007378: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2020. EXPIRATION DATE: 2025-09-13. 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

    SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON SUCCESSFULLY PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672268 LINER: MPACT FLAT PE HC 36/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2009609 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention