BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18693812 · Received February 13, 2024

    Report

    Report Number
    3005180920-2024-00026
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 14, 2024
    Report Date
    February 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 JANUARY 2024 LOT 1902875: (B)(4) MANUFACTURED AND RELEASED ON 27-MAY-2019. EXPIRATION DATE: 2024-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 15 JANUARY 2024 BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2111105: (B)(4) MANUFACTURED AND RELEASED ON 02-DEC-2021. EXPIRATION DATE: 2026-11-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 1 MONTH FROM THE PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765848 LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 1902875 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention