BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO NO-HOLE 54

    MDR report key: 12473172 · Received September 15, 2021

    Report

    Report Number
    3005180920-2021-00742
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807909
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2021: LOT 152059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUNE-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: ACETABULAR COMPONENT REVISION SURGERY PERFORMED 5 YEARS AND 9 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD MAN. NO INFORMATION CONCERNING PATIENT'S GENERAL HEALTH STATUS AND PRESENCE OF COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGES PROVIDED SHOW THE PRESENCE OF CUP MIGRATION. THE ORIGINAL POSITION OF THE CUP CANNOT BE ASSESSED NOT HAVING IMMEDIATE POSTOPERATIVE IMAGES. NO CONCLUSION CAN BE DRAWN ON THE BASIS OF EVIDENCE COLLECTED.

    Description of Event or Problem · 1

    5 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371607 CUP: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO NO-HOLE 54 CEMENTLESS ACETABULAR PROSTHESIS LZO MEDACTA INTERNATIONAL SA 01.26.45.1154 152059 07630030807909

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention