BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 48/28

    MDR report key: 17001455 · Received May 25, 2023

    Report

    Report Number
    3005180920-2023-00374
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MAY 2023: LOT 2206083: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 2027-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 4 MAY 2023. CUP: MPACT 01.32.148MB DOUBLE MOBILITY ACETABULAR SHELL Ø 48 (K143453) LOT. 2104161 LOT 2104161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JULY-2021. EXPIRATION DATE: 2026-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO JOINT DISLOCATION. THE SURGEON REVISED SUCCESSFULLY THE DM HEAD AND LINER TO A NEW DM LINER WITH A LARGER HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848657 LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 48/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2206083 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention