BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 RIGHT

    MDR report key: 5522934 · Received March 24, 2016

    Report

    Report Number
    3005180920-2016-00110
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    February 23, 2016
    Report Date
    June 22, 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 23 MAY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT.ON 02 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD THE PRIMARY SURGERY ON (B)(6) 2013 AND A POLY SWAP ON (B)(6) 2013 ((B)(4)). THE PRIMARY SURGERY WAS A MYKNEE CASE. ON (B)(6) 2016, THE MYKNEE DEPARTMENT PERFORMED A PATIENT MATCH PLANNING REVIEW AND COMMENTED AS FOLLOWS: THE ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. NO X-RAYS RECEIVED, SO NO FURTHER ANALYSIS IS POSSIBLE. ON (B)(6) 2016, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TKA REVISION AT THREE YEARS SINCE IMPLANTATION. FORMERLY, A PE SUBSTITUTION HAD BEEN EXECUTED. THERE ARE NO X-RAYS TO EVALUATE, BUT SEVERAL PICTURES REPRESENTING A NEAT SEPARATION BETWEEN CEMENT AND IMPLANT, AS IF POLYMERIZATION OF THE RESIN OCCURRED BEFORE INTERDIGITATION IN THE IMPLANT ASPERITIES COULD TAKE PLACE. THIS CAN HAPPEN BECAUSE OF TEMPERATURE PROBLEMS, SUCH AS A COLD IMPLANT, OR BECAUSE OF CEMENT PROBLEMS, AMONG OTHER REASONS LESS COMMON. NO REASON TO SUSPECT THAT A FAULTY IMPLANT ORIGINATED THE PROBLEM. ON (B)(6) 2016, THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE EXPLANTED COMPONENTS AND COMMENTED AS FOLLOWS: - FEMORAL COMPONENT NO RESIDUAL TRACES OF THE CEMENT WERE NOTED ON THE INTERNAL SURFACE OF THE COMPONENT. THE FINISHING OF THE INTERNAL SURFACES OF THE COMPONENT IN CONTACT WITH THE CEMENT SEEMS TO BE IN COMPLIANCE WITH THE SPECIFICATIONS REQUIRED. - TIBIAL COMPONENT SOME SMALL RESIDUAL TRACES OF THE CEMENT WERE NOTED ON THE DISTAL SURFACE OF THE BASEPLATE. DUE TO THE LOW-QUALITY RESOLUTION OF THE PICTURE, NO CONSIDERATIONS ON THE DEGREE OF FINISHING OF THE DISTAL SURFACE OF THE COMPONENT CAN BE DONE. BATCH REVIEW PERFORMED ON 21 MARCH 2016. LOT 120485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 APRIL 2012. EXPIRATION DATE: 2017-02-28. 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 TRAY FIXED CEMENTED SIZE 4 RIGHT, CODE 02.07.1204R, LOT. 125593 ((B)(4)) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MARCH 2013. EXPIRATION DATE: 2018-02-28. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A SECOND REVISION DUE TO PAIN IN THE RIGHT KNEE. THE SURGEON FELT THE PAIN WAS DUE TO LOOSENING OF THE COMPONENTS. THE SURGEON SAID THE BONE SCAN DID NOT SHOW LOOSENING BUT THE IMPLANTS BASICALLY FELL OUT. HE FELT IT COULD BE DUE TO THE CEMENT USED, WHICH WAS A NON-MEDACTA PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE NO X-RAYS OR EXPLANTS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180393 GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 RIGHT FEMUR PS CEMENTED JWH MEDACTA INTERNATIONAL SA 120485

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention