BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2

    MDR report key: 17117954 · Received June 13, 2023

    Report

    Report Number
    3005180920-2023-00449
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030806834
    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 1 JUNE 2023. LOT: 2218116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-SEP-27. 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. ADDITIONAL DEVICE INVOLVED, BATCH REVIEW PERFORMED ON 1 JUNE 2023: BALL HEADS: COCR 01.25.123 COCR, BALL HEAD 12/14 Ø 22 SIZE M 0 (K080885) LOT: 2214566 LOT: 2214566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-AUG-31. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, 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
    2191238 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 46/22.2 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2246MHC 2218116 07630030806834

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention