BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28

    MDR report key: 15468911 · Received September 22, 2022

    Report

    Report Number
    3005180920-2022-00711
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 SEPTEMBER 2022: LOT 2011775: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-FEB-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2117174: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2022. EXPIRATION DATE: 2027-FEB-14. 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

    AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827327 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28 HIP ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2011775 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention