BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 8822116 · Received July 24, 2019

    Report

    Report Number
    3005180920-2019-00632
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    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 11 JULY 2019: LOT 1810745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEBRUARY-2019 EXPIRATION DATE: 2024-01-29. ONE ANOMALY FOUND, NOT RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 JULY 2019: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 189636. LOT 189636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEBRUARY-2019 EXPIRATION DATE: 2024-02-05. 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 AN 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
    614931 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 1810745 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention