BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY LINER Ø 52/28

    MDR report key: 7052727 · Received November 22, 2017

    Report

    Report Number
    3005180920-2017-00686
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 22, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 17 NOVEMBER 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL HEAD AND POLYETHYLENE DOUBLE MOBILITY LINER REVISION OCCURRED 7 YEARS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. PRE-REVISION XRAYS ARE NOT SUPPLIED. ACCORDING TO THE REPORT, THE PATIENT WAS COMPLAINING ABOUT PAIN. 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. BATCH REVIEW PERFORMED ON 20 NOVEMBER 2017. LOT 092227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2009. EXPIRATION DATE: 2014-08-31. 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 22 NOVEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE IMAGES AND COMMENTED AS FOLLOWS: THE IMAGES SHOW THE LINER EXPLANTED: NO PARTICULAR SIGNS ARE VISIBLE, THE HEAD IS INTERNAL AND SOME BLOOD IS PRESENT IN THE EXTERNAL SURFACE AND INTERNALLY. FROM THE IMAGES IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT PRESENTED WITH EARLY STAGE OSTEOLYSIS AROUND THE PROXIMAL PORTION OF THE FEMUR. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833004 VERSAFITCUP DOUBLE MOBILITY LINER Ø 52/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 092227 07630030807336

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention