BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28

    MDR report key: 10738977 · Received October 27, 2020

    Report

    Report Number
    3005180920-2020-00753
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2020, LOT 2000166: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 104 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 1906462. BATCH REVIEW PERFORMED ON 08 OCTOBER 2020, LOT 1906462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 233 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 4 OTHER SIMILAR EVENTS REPORTED ON THE LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 14 DAYS AFTER THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203718 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28 ACETABULAR DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2000166 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention