BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28

    MDR report key: 8260594 · Received January 18, 2019

    Report

    Report Number
    3005180920-2018-01109
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    December 20, 2018
    Report Date
    January 18, 2019
    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 · 1

    BATCH REVIEW PERFORMED ON 17 JANUARY 2019. LOT 152106: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2015 . EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON JANUARY 17, 2019. 3 YEARS AFTER PRIMARY CEMENTLESS DM THR AN INTRAPROSTHETIC DISLOCATION OCCURRED. THE CERAMIC HEAD, REPORTEDLY MANUFACTURED BY A DIFFERENT COMPANY, DISLOCATED FROM THE PE LINER. THERE ARE NO INDICATIONS AS TO POSSIBLE CAUSES FOR THIS EVENT, SUCH AS TRAUMAS OR EXTREME MOVEMENTS. WE COULD NOT MEASURE EITHER THE HEAD OF THE PE INSERT AND VERIFY IF A TOLERANCE MISMATCH OCCURRED, BUT IT IS UNLIKELY GIVEN THE SIGNIFICANT TIME AFTER PRIMARY IMPLANTATION. NO DEFINITE REASON FOR THIS EVENT COULD BE ASCERTAINED WITH THE INFORMATION AT HAND. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON JANUARY 14, 2019 BY R&D PRODUCT MANAGER: PRELIMINARY VISUAL INVESTIGATION ON EXPLANTED COMPONENT SHOWS SIGNS OF FRICTION BETWEEN FEMORAL HEAD AND METAL CUP, RESULTING IN METAL TRANSFER ON FEMORAL HEAD AND WEAR OF THE ACETABULAR COMPONENT'S EDGE AND ARTICULATING SURFACE. SCRATCHES SIGNS ON THE PE LINER EDGE DUE TO EXTRACTION AND NON-COHERENT FUNCTION AFTER DISLOCATION.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 3 YEARS AND 1 MONTH AFTER PRIMARY SURGERY, DUE TO INTRA-PROSTHETIC DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP, MEDACTA LINER AND ANOTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54513 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 152106 07630030807473

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention