BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54

    MDR report key: 8464672 · Received March 29, 2019

    Report

    Report Number
    3005180920-2019-00208
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808128
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 MARCH 2019: LOT 173545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-11-14. 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

    INDEPENDENT SALES AGENT DID NOT HAVE THE IMPLANTS AVAILABLE FOR THE CASE WHICH CAUSED A DELAY IN THE OR. THE SURGEON DECIDED TO INTRAOPERATIVELY REPOSITION THE ACETABULAR CUP AFTER HE HAD IMPLANTED ALL THE COMPONENTS. TO WORK ON THE CUP, THE SURGEON HAD TO EXPLANT THE LINER AND FEMORAL HEAD. THE AGENT DID NOT HAVE A SECOND INVENTORY BANK AND HAD TO GET THE REPLACEMENT LINER AND HEAD FROM ANOTHER HOSPITAL. WE THINK THIS CAUSED A 20 - 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258483 CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54 CEMENTLESS ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 173545 07630030808128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention