BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM HC LINER 54/28

    MDR report key: 4909549 · Received July 9, 2015

    Report

    Report Number
    3005180920-2015-00143
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    October 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/28/2015 THE RETRIEVED ITEM HAVE BEEN ANALYZED BY (B)(4) PROJECT MANAGER WITH THE FOLLOWING OUTCOMES: OBSERVING THE EXPLANTED LINER ASSEMBLED WITH THE FEMORAL HEAD, SOME SCRATCHES ON THE EXTERNAL SURFACE OF THE LINER CAN BE NOTED, PROBABLY CAUSED BY THE EXTRACTION PHASE. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    ON 10 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND IN THE FOLLOW UP #1. ON 11 SEPTEMBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 07, 2015: LOT 150127: (B)(4) DEVICES MANUFACTURED AND RELEASED ON APRIL 20, 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. LOT 104628: (B)(4) HEADS MANUFACTURED AND RELEASED ON MARCH 30, 2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) HEADS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON JUNE 22, 2015, IT WAS VERIFIED THAT THIS WAS THE FIRST EVENTS ON THE LOTS INVOLVED IN THE COMPLAINT AND THAT THERE ARE NO OTHER EVENTS REGISTERED ON THE SAME STERILIZATION LOTS OF THE PIECES INVOLVED IN THE COMPLAINT. ON JULY 06, 2015, IT WAS COMMUNICATED THAT NO ADD'L INFO ABOUT PATOGEN WAS RECEIVED YET.

    Description of Event or Problem · 1

    IMP # 3006639916-2015-00143.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445401 VERSAFITCUP DM HC LINER 54/28 HC PE DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention