BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

    MDR report key: 10710583 · Received October 21, 2020

    Report

    Report Number
    3005180920-2020-00722
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2020: LOT 1910312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2020. EXPIRATION DATE: 2025-02-03. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2020. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K1121159 LOT. 177682 LOT 177682: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2018. EXPIRATION DATE: 2023-05-13. 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 PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178900 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 1910312 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention