BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL Ø 52

    MDR report key: 7360998 · Received March 22, 2018

    Report

    Report Number
    3005180920-2018-00170
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 22, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808098
    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 (B)(6) 2018 RE-REVISION OF ACETABULAR CUP IN CEMENTLESS THA. NO DOCUMENTATION IS AVAILABLE TO ANALYZE POSSIBLE CAUSES. IN THE POST-REVISION IMAGE, A VERY EVIDENT OSTEOPENIC AREA IS VISIBLE CRANIAL TO THE ACETABULAR CUP, CAUSES UNKNOWN, WHICH PROBABLY UNDERMINED STABILITY OF THE PREVIOUS CUP. NO FURTHER COMMENTS CAN BE EXPRESSED WITH THE INFORMATION AT HAND. BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 148343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 03/31/2020. 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. VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 REFERENCE 01.26.2852MHC (K092265) LOT 162321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 06/29/2021. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY CASE ON (B)(6) 2015. ON (B)(6) 2017 THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO STEM SUBSIDENCE. THE SURGEON REVISED THE PATIENT WITH ANOTHER COMPANY'S STEM AND HEAD AND A MEDACTA LINER [(B)(4)]. ON (B)(6) 2018 THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE CUP (IMPLANTED ON (B)(6) 2015) AND THE LINER (IMPLANTED ON (B)(6) 2017) AND THE OTHER COMPANY'S HEAD WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205627 VERSAFITCUP ACETABULAR SHELL Ø 52 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 148343 07630030808098

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention