BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 13976486 · Received April 1, 2022

    Report

    Report Number
    3005180920-2022-00216
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 10 MARCH 2022: LOT 2101757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2021. EXPIRATION DATE: 2026-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 10 MARCH 2022: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT 2011588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAR-2021. EXPIRATION DATE: 2026-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, 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
    900402 LINER: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 2101757 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention