BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 7309072 · Received March 2, 2018

    Report

    Report Number
    3005180920-2018-00106
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 152104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-06-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT VERSAFITCUP ACETABULAR SHELL Ø 56 REFERENCE 01.26.56MB (K083116) LOT 151050: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JULY 2015. EXPIRATION DATE: 2020-06-30 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 151721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-06-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT AMISTEM H HA COATED STD STEM SIZE 4 REFERENCE 01.18.134 (K093944) LOT 151442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 JUNE 2015. EXPIRATION DATE: 2020-05-30 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

    MEDACTA SALES REPRESENTATIVE HAS BEEN INFORMED ON (B)(6) 2018 BY THE SURGEON THAT THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON HAS SCHEDULED A REVISION FOR (B)(6) 2018. ON (B)(6) 2018 THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER AS PLANNED. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152999 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 152104 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention