BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28

    MDR report key: 14250701 · Received April 29, 2022

    Report

    Report Number
    3005180920-2022-00303
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 29, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 APRIL 2022: LOT 2109551: 110 ITEMS MANUFACTURED AND RELEASED ON 09-SEPT-2021. EXPIRATION DATE: 2026-08-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 06 APRIL 2022: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT 2100261: 130 ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2021. EXPIRATION DATE: 2026-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 75 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS AND A HALF AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114598 LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2854MHC 2109551 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention