BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE LINER Ø 28 / F

    MDR report key: 6913899 · Received October 4, 2017

    Report

    Report Number
    3005180920-2017-00546
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 4, 2017
    Report Date
    October 4, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802041
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION PERFORMED BY (B)(4) PROJECT MANAGER: THE LINER DATA WERE ANALYZED. THE POLYETHYLENE OF THE LINER APPEARED SLIGHTLY DEFORMED COMPARED TO THE NOMINAL VALUES. IN PARTICULAR, THE DIMENSIONAL CONTROL EVIDENCED A DEFORMATION OF ABOUT 0.1MM FOR THE DIAMETER OF THE INNER SPHERE AND A SINKING OF ABOUT 0.7MM TOWARDS THE POLAR REGION OF THE SHELL. CONSIDERING THAT THE LINER IS MANUFACTURED WITH STANDARD POLYETHYLENE (AND NOT HIGH CROSS), A SLIGHTLY DEFORMATION OCCURRED AFTER MORE THAN TEN YEARS CAN BE CONSIDERED ACCEPTABLE, ALSO CONSIDERING THE CLINICAL HYSTORY ABOUT THE LINERS IN STANDARD NOT CROSS-LINKED POLYETHYLENE.

    Additional Manufacturer Narrative · 1

    ON 15 SEPTEMBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TEN YEARS AFTER PRIMARY CEMENTLESS THA A REVISION BECAME NECESSARY FOR PROGRESSIVE STEM LOOSENING, PROBABLY DUE TO THE PRESENCE OF OSTEOLYTIC REGIONS IN THE PROXIMAL AREA. THE PRIMARY IMPLANT CONSISTED OF A STANDARD POLYETHYLENE INSERT; ALTHOUGH NO INFORMATION ON PATIENT AGE AND ACTIVITY LEVEL IS SUPPLIED, A SIGNIFICANT WEAR AFTER TEN YEARS IS TO BE CONSIDERED NORMAL AND ACCEPTABLE, AND MOST PATIENTS DEVELOP AN INFLAMMATORY RESPONSE TO POLYETHYLENE PARTICLES THAT OFTEN RESULT IN OSTEOLYSIS. THIS MAY BE THE MAIN CAUSE THAT LED TO REVISION. BATCH REVIEW PERFORMED ON 02 OCTOBER 2017. LOT 070104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2007. EXPIRATION DATE: 2012-02-29. 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. FLAT PE LINER Ø 28 / F, CODE 01.26.2848STT, LOT. 061043 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JULY 2006. EXPIRATION DATE: 2011-05-31. 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. ON 02 OCTOBER 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE COMPONENTS HAVE BEEN ANALYZED. THE STEM HAD THE COATING ALMOST TOTALLY ABSORBED, EXCEPT FOR SOME AREAS IN THE PROXIMAL PART; SOME SCRATCHES WERE VISIBLE ON THE NECK DUE TO THE EXTRACTION. THE CERAMIC BALL HEAD SHOWED SOME SIGNS OF REMOVAL ON THE RIM. THE VERSAFITCUP SHELL HAD THE COATING TOTALLY ABSORBED WITH SOME FIBROTIC TISSUE IN THE MACROSTRUCTURES. THE LINER PE, STILL INSIDE THE SHELL, SHOWED A RUINED BASE SLIGHTLY DEFORMED ON THE RIM. THE INNER PART OF THE LINER WILL BE DEEPLY ANALYSED BY QUALITY CONTROL DEPARTMENT.

    Description of Event or Problem · 1

    REVISION PERFORMED DUE TO POLY WEAR. HEAD EXCENTRIC FOUND IN THE RX. THE STEM WAS COMPLETELY LOOSE, THE CUP WAS WELL INTEGRATED. THE SURGEON EXPLANTED ALL COMPONENTS.

    Description of Event or Problem · 1

    REVISION PERFORMED DUE TO POLY WEAR. HEAD EXCENTRIC FOUND IN THE RX. THE STEM WAS COMPLETELY LOOSE, THE CUP WAS WELL INTEGRATED. THE SURGEON EXPLANTED ALL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692954 LINER: CC E CC LIGHT FLAT PE LINER Ø 28 / F FLAT PE LINER FOR HIP LZO MEDACTA INTERNATIONAL SA 061043 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention