BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT

    MDR report key: 6886396 · Received September 22, 2017

    Report

    Report Number
    3005180920-2017-00530
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    August 24, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862557
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT MATCH DEPARTMENT REVIEW OF THE CASE: EACH STEP OF THE MYKNEE PROCESS HAS BEEN REVIEWED AND NO ERRORS HAVE BEEN FOUND. AS NO X-RAY WAS PROVIDED, IT WAS NOT POSSIBLE TO PERFORM ANY FURTHER ANALYSIS. OUR ANALYSIS OF THE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2017. LOT 152447: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2015. EXPIRATION DATE: 2020-10-13. 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 20 SEPTEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE EVENT DESCRIPTION AND ON THE PICTURES OF THE EXPLANTED UHMWPE INSERT, AND COMMENTED AS FOLLOWS: REVISION DUE TO PAIN AND REDUCED KNEE FLEXION 7 MONTHS POST PRIMARY. FEMORAL LIFT OFF ON MEDIAL SIDE AT ABOUT 90* FLEXION. IT IS NOT POSSIBLE TO IDENTIFY ANY POSSIBLE ROOT CAUSE FOR THE EVENT THAT IS POTENTIALLY IMPLANT RELATED. UPON REMOVAL OF THE POLY INSERT, YELLOW MARKINGS WERE FOUND. THIS TURNING OF THE COLOR INTO YELLOW IN SOME PORTIONS OF THE UHMWPE COMPONENTS, IS SOMETHING ALREADY EXPERIENCED AND DEEPLY ANALYZED IN MEDACTA. THIS IS SOMETHING THAT AFFECTS ONLY THE EXTERNAL SURFACES OF THE INSERT AND NOT RELATED TO ABNORMAL OXIDATION OF THE LINER. SPECIFIC TESTING TO EVALUATE THE OXIDATION INDEX (OI) HAS BEEN PERFORMED ON SIMILAR PRODUCT THAT "IN VIVO" TURNED ITS COLOUR INTO YELLOW. AS RESULTS OF THOSE STUDIES, THE OI INDEX OF THE EXPLANTED LINER WAS COMPARABLE WITH THE OI OF A LINER ANALYZED AFTER ACCELERATING AGING WITH THE EXCEPTION OF THE SURFACE. ACCORDING TO THE STUDY PUBLISHED BY COSTA ET AL "ANALYSIS OF PRODUCTS DIFFUSED INTO UHMWPE PROSTHETIC COMPONENTS IN VIVO", THE APOLAR COMPONENTS OF SYNOVIAL LIQUID SUCH AS CHOLESTEROL, FATTY ACID, ESTERS OF CHOLESTEROL AND SQUALENE ARE ABLE TO DIFFUSE INTO UHMWPE. THEREFORE THE REASON OF THE CHANGE OF THE COLOR SHOULD BE THE ABSORPTION OF LIPIDS FROM THE SYNOVIAL FLUID PRESENT IN THE JOINT OF THE PATIENT.

    Description of Event or Problem · 1

    KNEE REVISION DUE TO PAIN AND REDUCED KNEE FLEXION 7 MONTHS AFTER PRIMARY RTKR. FEMORAL LIFT OFF ON MEDIAL SIDE AT ABOUT 90° FLEXION. UPON REMOVAL OF 13MM POLY INSERT THERE APPEARED TO BE YELLOW MARKINGS ON INSERT SUGGESTING OXIDISATION OF POLYETHYLENE INSERT. LIKELY POOR FLEXION POST-OP DUE TO NOT ENOUGH POSTERIOR SLOPE APPLIED TO TIBIA. ROM IMPROVED WITH SCAR RELEASES AND TISSUE RELEASES. POLY INSERT DOWNSIZED TO 12MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668339 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 152447 07630030862557

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention