BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 12843240 · Received November 19, 2021

    Report

    Report Number
    3005180920-2021-00892
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE 19TH OF NOVEMBER AFTER THE INITIAL REPORT WAS SENT WE HAVE RECEIVED SOME NEW INFORMATION. BATCH REVIEW PERFORMED ON 01-DEC-2021: LOT 160847: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 21-APRIL-2016. EXPIRATION DATE: 2021-04-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO HIP INLAY BREAKAGE 4 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT FELL AND DISLOCATED THE HIP.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO HIP INLAY BREAKAGE, THE PATIENT FELL. IT IS UNKNOWN THE PRIMARY SURGERY DATE AND ALL OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739865 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 ACETABULAR DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 160847
    1739867 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 ACETABULAR DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 160847

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention