BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2860MHC DOUBLE MOBILITY HC LINER Ø 60/28

    MDR report key: 17350437 · Received July 19, 2023

    Report

    Report Number
    3005180920-2023-00521
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 19, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807473
    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 26 JUNE 2023. LOT 182649: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-JUN-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 (K112115) LOT 1907365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN.2020. EXPIRATION DATE: 2025-JAN-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY DATE, 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
    42940 LINER: VERSAFITCUP DM 01.26.2860MHC DOUBLE MOBILITY HC LINER Ø 60/28 HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2860MHC 182649 07630030807473

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention