BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 56

    MDR report key: 9698516 · Received February 12, 2020

    Report

    Report Number
    3005180920-2020-00042
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23 JANUARY 2020: LOT 181700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUNE-2018. EXPIRATION DATE: 2023-06-11. 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 1-1-2016. ADDITIONAL ITEMS INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON 23 JANUARY 2020 LINER: CC E CC LIGHT 01.26.3648HCT FLAT PE HC LINER Ø 36 / F LOT. 187921 LOT 187921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2018. EXPIRATION DATE: 2023-11-09. 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. STEM: AMISTEM C 01.18.436 AMISTEM-P COLLARED STD STEM #6 LOT. 1901536 LOT 1901536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2019. EXPIRATION DATE: 2024-05-07. 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 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 LOT. 1903863 LOT 1903863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JULY-2019. EXPIRATION DATE: 2024-07-15. 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. ABOUT A MONTH AFTER PRIMARY THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED NEW COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161828 CUP: VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 56 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0056 181700 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention