BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH

    MDR report key: 18482447 · Received January 10, 2024

    Report

    Report Number
    3005180920-2023-01076
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2023: LOT 2243169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-04. 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 DEVICE INVOLVED IN THE COMPLAINT: BATCH REVIEW PERFORMED ON 21 DECEMBER 2023: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2211892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2022. EXPIRATION DATE: 2027-07-27. 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

    THE PATIENT CAME IN REPORTING AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT ABOUT 4 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142008 LINER: MPACT 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 2243169 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention