BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 13001311 · Received December 14, 2021

    Report

    Report Number
    3005180920-2021-01006
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 3 DECEMBER 2021. LOT 2105778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2021. EXPIRATION DATE: 2026-JUN-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 3 DECEMBER 2021. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2101448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2021. EXPIRATION DATE: 2026-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    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
    1898021 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 2105778 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention