BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52

    MDR report key: 8906040 · Received August 19, 2019

    Report

    Report Number
    3005180920-2019-00687
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 2 AUGUST 2019 BY REGULATORY AFFAIRS DEPARTMENT: LOT 188880: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2 APRIL 2019. EXPIRATION DATE: 2024-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT. 1810745. BATCH REVIEW PERFORMED ON 2 AUGUST 2019 BY REGULATORY AFFAIRS DEPARTMENT: LOT 1810745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 FEBRUARY 2019. EXPIRATION DATE: 2024-01-29. 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

    REVISION SURGERY PERFORMED AFTER 4 DAYS FROM THE PRIMARY DUE TO PAIN CAUSED BY A DISLOCATION OF THE LINER FROM THE DM SHELL. THE PATIENT DISLOCATED DUE TO AN AMPUTATED LEFT PELVIS AND LEG. THE SURGEON REVISED THE LINER, CUP AND THE HEAD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700607 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø52 ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 188880 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention