BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL 58

    MDR report key: 10487424 · Received September 3, 2020

    Report

    Report Number
    3005180920-2020-00576
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 4, 2020
    Report Date
    December 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808203
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: IT IS POSSIBLE THAT A SIZING OCCURRED DUE TO AN INCORRECT USAGE: - WRONG SCREWING OF THE SHELL VERSAFICUP #58 DM REF.01.26.10.0139 WITH THE IMPACTING RING #58 REF.01.26.10.0139

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13.08.2020: LOT 160207: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-MAY-2016. EXPIRATION DATE: 2021-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT: CUP: VERSAFITCUP CC TRIO 01.26.45.1158 ACETABULAR SHELL CC TRIO NO-HOLE Ø 58 LOT. 2000144 (K122911). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13.08.2020: LOT 2000144 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2020. EXPIRATION DATE: 2025-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON WANTED TO IMPLANT A VERSAFITCUP DM S58 AND AFTER HE HAD A PRESS-FIT THE IMPACTING RING DID NOT COME OFF. BY TRYING SEVERAL TIMES AFTERWARD ALSO WITH A VERSAFITCUP CC TRIO HE HAD TO CEMENT A NEW ONE- APRICOT. THE BONE STRUCTURE WAS DAMAGED. THE SURGEON CEMENTED A NEW CUP ON THE BONE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954936 CUP: VERSAFITCUP ACETABULAR SHELL 58 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.58MB 160207 07630030808203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other