BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM PE LINER

    MDR report key: 5697067 · Received June 3, 2016

    Report

    Report Number
    3005180920-2016-00265
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    May 6, 2016
    Report Date
    July 22, 2016
    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 27 JUNE 2016 THE (B)(4) MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: AFTER THE VISUAL INSPECTION WE HAVE NOTHING TO UNDERLINE. THE PIECES APPEAR ABSOLUTELY NORMAL. THERE IS NO SIGN OF ABNORMAL WEAR. ON 07 JULY 2016 THE CONTROL QUALITY PERFORMED A METROLOGICAL ANALYSIS ON THE RETRIEVED LINER: THE INTERNAL DIAMETER MEASURED WAS IN COMPLIANCE WITH THE DRAWING.. ON 22 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION REPORTED IN THE INITIAL REPORT AND HERE ABOVE: BASED ON THE INVESTIGATIONS PERFORMED THE OSTEOLYSIS REPORTED IS UNLIKELY DEVICE RELATED. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 17 MAY 2016 AND INCLUDES: THE SURGEON REVISED THE LINER AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON 20 MAY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: SIGNIFICANT OSTEOLYSIS IN A WELL FIXED AND CORRECTLY IMPLANTED THA AT 6+ YEARS POSTOPERATIVE. FROM X-RAYS ONLY, THE ROOT CAUSE CANNOT BE ESTABLISHED. IN ORDER TO VERIFY IF POLYETHYLENE WEAR WAS ABNORMAL AND LIKELY TO HAVE CAUSED THE PROBLEM, THE EXPLANTS SHOULD BE EXAMINED. BATCH REVIEWS PERFORMED ON 01 JUNE 2016. LOT. 092438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 NOVEMBER 2009. EXPIRATION DATE: 2014-09-30. 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. COCR BALL HEAD 12/14 Ø 28SIZE L, CODE 01.25.013, LOT 092186 (K072857): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2009. EXPIRATION DATE: 2014-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON PLANS FOR A REVISION/EXPLORATION.X-RAYS ARE AVAILABLE. EXPLANTS WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351363 VERSAFITCUP DM PE LINER ACETABULAR PE LINER MEH MEDACTA INTERNATIONAL SA 092438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention