BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

    MDR report key: 6964502 · Received October 20, 2017

    Report

    Report Number
    3005180920-2017-00596
    Event Type
    Injury
    Date Received
    October 20, 2017
    Report Date
    October 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 OCTOBER 2017 THE PATIENT MATCH DEPARTMENT PROVIDED A PROCESS REVIEW REPORTING AS FOLLOWS: OUR ANALYSIS OF THE PLANNING PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. ON 19 OCTOBER 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PARTIAL REVISION OF PRIMARY CEMENTED TKA AFTER 3 YEARS. A FIXED, ULTRA-CONGRUENT TIBIAL BASEPLATE WAS REPLACED WITH A THICKER INSERT AND A STEMMED IMPLANT. THE PRIMARY IMPLANTATION APPEARS TO HAVE VERY PRONOUNCED POSTERIOR SLOPE OF THE TIBIAL COMPONENT AND A LATERAL SHIFT; THESE CONDITIONS MAY RESULT IN (POSTERIOR, PROBABLY) INSTABILITY OF THE JOINT, DEPENDING ON LIGAMENT CONDITIONS AND PATIENT ACTIVITY AND FITNESS. WE HAVE NO INFORMATION AS TO THE CONDITIONS THAT LED TO THIS PARTICULAR PLACEMENT. THERE IS NO REASON TO SUSPECT A FAULTY IMPLANT AT THE ORIGIN OF THE PROBLEM. BATCH REVIEWS PERFORMED ON 20 OCTOBER 2017. LOT 144885: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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. GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM, CODE 02.07.0310FUC, LOT. 141645 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE REVISION SURGERY WAS SUCCESSFULLY. THE SURGEON REMOVED THE TIBIA BASEPLATE, CORRECTED THE SLOPE AND REIMPLANTED A FIXED TIBIA BASEPLATE CEMENTED SIZE 3 WITH A SHORT STEM (11/65MM) AND A UC FIXED INSERT SIZE 3/17MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744396 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 144885 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention