BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY CEMENTED FEMUR STD SIZE 3 RIGHT

    MDR report key: 5239223 · Received November 20, 2015

    Report

    Report Number
    3005180920-2015-00274
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 20, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 19 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 25 JANUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 IT WAS COMMUNICATED THAT: THE SURGEON SUSPECTED AN INFECTION. WAITING FOR PATHOLOGY RESULTS. ANTIBIOTIC SPACERS WERE PUT IN WHEN THE MEDACTA PRODUCTS WERE REMOVED. ON (B)(6) 2015 IT WAS ADDED THAT THE PATHOLOGY RESULTS WERE NOT MADE AVAILABLE. INFECTION WAS CONFIRMED BATCH REVIEW PERFORMED ON 17 NOVEMBER 2015: GMK-PRIMARY FEMUR STD CEMENTED # 3 R CODE 02.07.2003R LOT. 131803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JULY 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL INSERT STD FIXED # 2 / 17 MM CODE 02.07.0217SF LOT. 103352 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 NOVEMBER 2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED # 2 R CODE 02.07.1202R LOT. 131929 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JULY 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. INVESTIGATION PERFORMED ON THE 20TH OF NOVEMBER 2015 BY R&D PROJECT MANAGER: VISUAL INSPECTION ON THE EXPLANTED FEMORAL COMPONENT: MULTIPLE SCRATCHES AND INCISIONS WERE FOUND ON THE ARTICULAR SURFACE OF THE COMPONENT. THEY WERE LIKELY CAUSED BY THE INSTRUMENTS USED TO EXPLANT THE CEMENTED IMPLANT. VISUAL INSPECTION ON THE TIBIAL BASEPLATE: SOME SCRATCHES AND INCISIONS WERE FOUND ON THE UPPER SURFACE OF THE COMPONENT. THEY WERE LIKELY CAUSED BY THE INSTRUMENTS USED TO EXPLANT THE IMPLANT. VISUAL INSPECTION ON THE UHMWPE LINER: THE INSERT WAS FOUND REGULARLY WORN-OUT. ANTERIOR CLIPPING SYSTEM WAS FOUND DAMAGED. THIS WAS PROBABLY BROKEN DURING THE EXPLANTATION OF THE INSERT. CONCLUSION: NO POSSIBLE CAUSES OF PAIN HAVE BEEN IDENTIFIED FROM VISUAL INSPECTION. THE PAIN OF THE PATIENT WAS LIKELY CAUSED BY THE INFECTION, THAT WAS CONFIRMED AFTER EXPLANTATION. THE EVENT WAS NOT IMPLANT/PROCEDURE RELATED.

    Description of Event or Problem · 1

    PATIENT CAME IN COMPLAINING OF PAIN. SURGEON DECIDED TO WASH OUT THE KNEE AND REMOVE ALL COMPONENTS. EXPLANTS WILL BE RETURNED FOR ANALYSIS. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769766 GMK PRIMARY CEMENTED FEMUR STD SIZE 3 RIGHT CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 131803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention