BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

    MDR report key: 7498737 · Received May 9, 2018

    Report

    Report Number
    3005180920-2018-00315
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807435
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 04 MAY 2018; 9 YEARS AFTER PRIMARY CEMENTLESS DOUBLE-MOBILITY THA THE HIP BECAME PAINFUL, PROBABLY BECAUSE OF OSTEOLYTIC REACTION WHICH MAY HAVE BEEN CAUSED BY POLYETHYLENE DEBRIS. WE CANNOT DETERMINE THIS CHAIN OF EVENTS FROM THE DOCUMENTATION SUPPLIED, BUT THIS IS POSSIBLE AND, AFTER 9 YEARS OF ACTIVE LIFE OF A NON-CROSSLINKED PE MOBILE INSERT, COMPATIBLE WITH CURRENT LITERATURE. BOTH STEM AND CUP WERE NOT LOOSE. BATCH REVIEW PERFORMED ON 07 MAY 2018; LOT 083130: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2008. EXPIRATION DATE: 2013-10-31. 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. OTHER DEVICE INVOLVED: VERSAFITCUP ACETABULAR SHELL Ø 58 01.26.58MB (K083116); LOT 090081: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2009. EXPIRATION DATE: 2014-02-28; 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 09 MAY 2018 FROM THE IMAGE OF THE IMPLANTS NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ABOUT 9 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR OSTEOLYSIS DUE TO POLY WEAR. THE SURGEON REVISED THE CUP, THE LINER AND THE BALL HEAD. THE STEM WAS WELL FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342456 VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28 LINER DOUBLE MOBILITY MEH MEDACTA INTERNATIONAL SA 083130 07630030807435

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention