BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28

    MDR report key: 9710886 · Received February 14, 2020

    Report

    Report Number
    3005180920-2020-00061
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807404
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 JANUARY 2020. LOT 092876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2010. EXPIRATION DATE: 2014-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: 10 YEARS AFTER DUAL-MOBILITY CEMENTLESS THA SOME OSTEOLYTIC REGIONS ARE VISIBLE IN THE PROXIMAL FEMUR. THE CUP IS REPLACED AND THE FEMORAL CAVITIES APPARENTLY FILLED WITH BONE CHIPS. IT IS POSSIBLE THAT AFTER TEN YEARS, THE WEAR PRODUCTS OF THE STANDARD-PE DM LINER HAVE CONTRIBUTED TO CAUSING OSTEOLYSIS. THIS IS IN LINE WITH FINDINGS REPORTED IN LITERATURE AND SHOULD NOT BE CONSIDERED AN ANOMALOUS BEHAVIOUR. VISUAL INSPECTION PERFORMED BY MEDACTA R&D DÉPARTEMENT: FROM THE PIECES ANALYZED, NO PARTICULAR SIGNS WERE NOTICED; SOME REMAINED PARTS OF BONE WERE PRESENT IN THE MACROSTRUCTURES OF THE CUP AND NO PARTICULAR SIGNS WERE PRESENT IN THE SYSTEM CUP-LINER-HEAD. FROM THE RECEIVED INFORMATION, IT IS POSSIBLE THAT A WEAR OF THE STANDARD PE CAUSED THE OSTEOLYSIS.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN. LINER, HEAD AND ACETABULAR SHELL WERE EXPLANTED ON THE (B)(6) 2019 AND OSTEOLYSIS WAS NOTICED. THE PRIMARY SURGERY PERFORMED ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 JANUARY 2020: LOT 092876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2009. EXPIRATION DATE: 2014-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT HAD PAIN. THE PROSTHESIS WAS EXPLANTED ON (B)(6) 2019 AND OSTEOLYSIS WAS NOTICED. PRIMARY DETAILS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173384 LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28 DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856M 092876 07630030807404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention