BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY LINER Ø 58/28

    MDR report key: 6640049 · Received June 14, 2017

    Report

    Report Number
    3005180920-2017-00303
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 JUNE 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL HIP REVISION SURGERY IN A YOUNG MAN ((B)(6) YEARS) 7 YEARS AND 8 MONTHS AFTER PRIMARY DOUBLE MOBILITY THA. RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF OSTEOLYSIS AROUND THE STEM PROBABLY CAUSED BY POLYETHYLENE WEAR. AN AMOUNT OF WEAR WITH THE REPORTED CLINICAL IMPLICATIONS DOES NOT APPEAR TO BE ABNORMAL GIVEN THE AGE OF THE PATIENT AND THE TYPE OF COMPONENTS CHOSEN FOR THE PRIMARY OPERATION. BATCH REVIEW PERFORMED ON 12 JUNE 2017. LOT 090902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 AUGUST 2009. EXPIRATION DATE: 2014-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 14 JUNE 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE IMAGES AND COMMENTED AS FOLLOWS: THE EXTERNAL SURFACE OF THE LINER SEEMS TO BE BURNISHED, MAINLY IN THE POLAR REGION; THE YELLOW ASPECT IS PROBABLY CAUSED BY LIPID ABSORPTION. FROM THE IMAGES AVAILABLE NO CONCLUSION CAN BE DRAWN. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME INTO THE SURGEON'S OFFICE FOR A ROUTINE FOLLOW-UP. THE SURGEON OBSERVED ON A NEW X-RAY, OSTEOLYSIS AROUND THE STEM. THE STEM AND CUP WERE WELL FIXED. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421329 VERSAFITCUP DOUBLE MOBILITY LINER Ø 58/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 090902

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention