BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 17215240 · Received June 28, 2023

    Report

    Report Number
    3005180920-2023-00492
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    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 13 JUNE 2023: LOT 2116151: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 154 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2113556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2021. EXPIRATION DATE: 2026-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 131 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY, THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702204 LINER: MPACT 01.26.2848MHC DOUBLE MOBILITY HC LINER 28/DMD HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2116151 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention