BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28

    MDR report key: 11176028 · Received January 15, 2021

    Report

    Report Number
    3005180920-2021-00051
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 18, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807404
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 DECEMBER 2020 LOT 092229: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-OCT-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 SINCE 2016. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR TEN YEARS AFTER PRIMARY UNCEMENTED DOUBLE MOBILITY THA, THE PATIENT REPORTS LEG LENGTH DIFFERENCE. IT'S POSSIBLE THAT THE NON-MEDACTA STEM HAS SUBSIDED, BUT THIS CANNOT BE VERIFIED BECAUSE NO XRAY HISTORY IS AVAILABLE. AT THE PRE-REVISION XRAYS, HOWEVER, THE CUP DOES NOT LOOK LIKE HAVING UNDERGONE MIGRATION. THE MEDACTA DM LINER WAS EXCHANGED AS PER ROUTINE PROCEDURE, BUT THERE IS NO INDICATION THAT IT WAS FAULTY OR NON-PERFORMING ADEQUATELY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 10 YEARS AND 11 MONTHS REPORTING A LEG LENGTH DISCREPANCY (THE CAUSE IS UNKNOWN). THE SURGEON REVISED THE NON-MEDACTA HEAD AND THE MEDACTA LINER WITH A NON-MEDACTA HEAD AND A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77521 LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28 ACETABULAR DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856M 092229 07630030807404

    Patients

    Seq Age Sex Outcome Treatment
    1