BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMF

    MDR report key: 7938082 · Received October 5, 2018

    Report

    Report Number
    3005180920-2018-00756
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807336
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 OCTOBER 2018. LOT 092227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2009. EXPIRATION DATE: 201-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIR MANAGER ON OCTOBER 04, 2018. FEMORAL HEAD AND POLYETHYLENE DOUBLE MOBILITY LINER REVISION OCCURRED 9 YEARS AFTER PRIMARY IMPLANTATION. ACCORDING TO THE SURGEON, THE REASON OF THIS EVENT IS OSTEOLYSIS. OSTEOLYSIS MAY BE THE CONSEQUENCE OF POLYETHYLENE WEAR THAT IS COMMONLY SEEN AND DESCRIBED IN LITERATURE, HOWEVER WEAR WAS NOT MEASURED IN THIS CASE AND THEREFORE CORRELATION IS NOT ESTABLISHED. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON SEPTEMBER 18, 2018 PRELIMINARY VISUAL INVESTIGATION ON PE LINER HIGHLIGHTS CERAMISIS-LIKE AREA EXTENDING FROM THE POLAR REGION TOWARDS THE EQUATOR. THIS SUGGESTS THAT THE PREDOMINANT WEAR MECHANICS WAS BURNISHING, WHICH IS ALSO IN LINE WITH THE CLINICAL OUTCOME AND REASON FOR REVISION. PE LINER COLOR IS DUE TO BIOLOGIC FLUIDS ABSORPTION AND POSSIBLE OXIDATION EFFECTS DURING THE LONG TERM IN-SITU TIME. IN-HOUSE VISUAL INSPECTION IS SUGGESTED.

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW UP VISIT, THE SURGEON NOTICED OSTEOLYSIS ON THE X-RAY 9 YEARS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780554 VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMF DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 092227 07630030807336

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention