BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 54

    MDR report key: 6331854 · Received February 15, 2017

    Report

    Report Number
    3005180920-2017-00038
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    February 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS HAD PAIN FOR MONTHS. AT FIRST, A REVISION SURGERY HAS BEEN PLANNED DUE TO PROBABLE STEM LOOSENING. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2017 AND INCLUDES: THE SURGEON SUSPECTED CUP MALPOSITIONING DURING PRIMARY SURGERY BY HIMSELF INSTEAD OF STEM LOOSENING. THE EVENT WILL BE CONFIRMED AT REVISION. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2017 AND INCLUDES: THE REVISION WAS DONE ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 14 FEBRUARY 2017 AND INCLUDES: THE STEM AND THE CUP WERE NOT LOOSE. THE STEM WAS REVISED DUE TO PAIN AND THE CUP WAS REVISED DUE TO MALPOSITIONING IN PRIMARY. BATCH REVIEW PERFORMED ON 14 FEBRUARY 2017. LOT 150143: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-03-31. 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. BATCH REVIEW PERFORMED ON 15 FEBRUARY 2017. LOT 154182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 OCTOBER 2015. EXPIRATION DATE: 2020-04-10. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    STEM REVISION DUE TO PAIN AND CUP REVISION DUE TO MALPOSITIONING IN PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113673 VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 54 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 154182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention