BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 20143208 · Received September 5, 2024

    Report

    Report Number
    3005180920-2024-00706
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 6, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A RANDOM MDR CHECK CONDUCTED ON OCTOBER 1, 2024, AN ERROR WAS NOTICED. A FOLLOW-UP IS BEING INITIATED TO CORRECT IT. B3 EVENT DATE CORRECTED. D1 BRAND NAME CORRECTED. D4 MODEL NUMBER INSERTED IN THE CORRECT FIELD. G4 (K) NUMBER INSERTED IN THE CORRECT FIELD.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-AUG-2024. LOT 153654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO IMPINGEMENT WITH THE DUAL MOBILITY LINER AND ILIOPSOAS, 8 YEAR AND 8 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPLACED THE HEAD WITH A +7 OPTION SLEEVE AND NEW DUAL MOBILITY LINER. HE WITNESSED A SIGNIFICANT AMOUNT OF SCAR TISSUE AROUND THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832878 DOUBLE MOBILITY LINER HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 153654 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention