BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL 48

    MDR report key: 11331088 · Received February 16, 2021

    Report

    Report Number
    3005180920-2021-00129
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 16, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808036
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 2 FEBBRAIO 2021: LOT 091607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-AUG-2009. EXPIRATION DATE: 2014-06-30. 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 2017. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 2 FEBBRAIO 2021: LINER: VERSAFITCUP DM 01.26.2848M DOUBLE MOBILITY LINER Ø 48/28 (K083116) LOT 092004: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2009. EXPIRATION DATE: 2014-07-31. 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 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 10 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM WITH A COMPETITOR STEM, THE MEDACTA CUP WITH A COMPETITOR CUP, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232036 VERSAFITCUP ACETABULAR SHELL 48 HIP CEMENTLESS CUP MEH MEDACTA INTERNATIONAL SA 01.26.48MB 091607 07630030808036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention