BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28

    MDR report key: 11626446 · Received April 7, 2021

    Report

    Report Number
    3005180920-2021-00276
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 2006365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2020. EXPIRATION DATE: 2025-07-21. 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 IMPLANT INVOLVED: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT. 2006277. BATCH REVIEW PERFORMED ON 17 MARCH 2021: LOT 2006277: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2020. EXPIRATION DATE: 2025-08-25. 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 1 MONTH AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528042 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 48/28 DOUBLE MOBILITY ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2006365 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention