BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL 50

    MDR report key: 10513712 · Received September 10, 2020

    Report

    Report Number
    3005180920-2020-00589
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808067
    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 21 AUGUST 2020: LOT 1906132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-22. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 21 AUGUST 2020: STEM: AMISTEM P 01.18.402 AMISTEM-P STD STEM SIZE 2 LOT. 1904135 LOT 1904135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-20. 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 BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 LOT. 183338. LOT 183338: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2018. EXPIRATION DATE: 2023-09-23. 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 LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 LOT. 1906159. LOT 1906159: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-03. 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 CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 2 MONTHS AFTER PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979051 CUP: VERSAFITCUP ACETABULAR SHELL 50 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.50MB 1906132 07630030808067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention