BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 50

    MDR report key: 5916990 · Received August 31, 2016

    Report

    Report Number
    3005180920-2016-00441
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 SEPTEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEW DAYS AFTER PRIMARY THA THE SURGEON FELT THE CUP NEEDED REPOSITIONING. THERE IS NO INFORMATION AS TO A POSSIBLE CUP MIGRATION OR MOVEMENT. THE SUPPLIED X-RAYS DO NOT ALLOW ANY EVALUATION OF THIS CASE; IT IS NOT EVEN KNOWN IF THE ONE IMAGE IS THE IMMEDIATE PRIMARY POSTOPERATIVE OR PRE-REVISION. NO REASON TO THINK THAT A MALFUNCTIONING DEVICE ORIGINATED THE PROBLEM.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 AUGUST 2016. LOT 132314: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2013. EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON WAS UNHAPPY WITH THE CUP POSITION A FEW DAYS POST-OP. THE SURGEON REVISED THE CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569804 VERSAFITCUP ACETABULAR SHELL Ø 50 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 132314

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention