BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28

    MDR report key: 10161719 · Received June 17, 2020

    Report

    Report Number
    3005180920-2020-00341
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    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 28 MAY 2020: LOT 1905491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEPT-2019. EXPIRATION DATE: 2024-09-01. 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. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION 28 (K131518) LOT. 1906491. BATCH REVIEW PERFORMED ON 28MAY 2020: LOT 1906491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-14. 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 ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL (K131518) LOT. 1811867. BATCH REVIEW PERFORMED ON 28 MAY 2020: LOT 1811867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2024-03-15. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. 4 MOTHS AFTER PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, OPTION SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE AGENT STATED THAT ANOTHER COMPANY'S STEM AND CUP WERE ALSO EXPLANTED AND THAT AN ANTIBIOTIC SPACER WAS IMPLANTED. NO NEW MEDACTA COMPONENTS WERE IMPLANTED DURING THIS REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625087 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 56/28 DOUBLE MOBILITY ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 1905491 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention