BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 8841176 · Received July 30, 2019

    Report

    Report Number
    3005180920-2019-00661
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 JULY 2019: LOT 1810742: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2019. EXPIRATION DATE: 2024-JAN-27. 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. ADDITIONAL IMPLANT: LINER: MPACT 01.32.4248MC DM CONVERTER LINER F/DME (K131458) LOT. 188908. BATCH REVIEW PERFORMED ON 23 JULY 2019: LOT 188908: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2018. EXPIRATION DATE: 2023-NOV-29. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, THE PATHOGEN IS UNKNOWN, 1 MONTH AFTER THE PREVIOUS SURGERY. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD TWO PREVIOUS REVISION SURGERIES DUE TO DIFFERENT REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635665 MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28 CEMENTLESS ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 1810742 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention