BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 12932364 · Received December 6, 2021

    Report

    Report Number
    3005180920-2021-00962
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 12, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 NOVEMBER 2021. LOT 2101757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-21. 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 ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 NOVEMBER 2021: CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453) LOT. 2011702. LOT 2011702: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APRIL-2021. EXPIRATION DATE: 2026-03-29. 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 · 0

    AT 7 YEARS 5 MONTHS THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA. IT WAS ALSO OBSERVED THAT THE SCREW HAD BACKED OUT OF THE POLY. THE REASON FOR THE LOOSE TIBIA AND THE LOOSE SCREW IS UNKNOWN. THE SURGEON REVISED THE FEMUR, TIBIA, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833292 LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 2101757 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention