BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PS CEMENTED FEMUR SIZE 3 RIGHT

    MDR report key: 5261835 · Received December 2, 2015

    Report

    Report Number
    3005180920-2015-00299
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    November 2, 2015
    Report Date
    February 24, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09 NOV 2015 THE CASE WAS CHECKED WITHIN PATIENT MATCH DEPARTMENT: NO ANOMALIES SEEN IN THE STEPS OF THE SURGERY PLAN. WE MADE A POST-OP ANALYSIS: WE OVERLAPPED THE 3D BONE MODEL OF THE TIBIA CUT AND THE FEMUR CUT AND THE X-RAYS WE RECEIVED: RESPECT TO OUR PLANNING, THE TIBIAL COMPONENT HAS BEEN IMPLANTED IN ABOUT 4° OF VALGUS, AND THE FEMORAL COMPONENT HAS BEEN IMPLANTED IN ABOUT 6° OF VARUS. PLEASE CONSIDER THAT THE X-RAY IS NOT EXACTLY FRONTAL; SO THESE VALUES COULD BE NOT VERY PRECISE. ON 30 NOV 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: ONLY ONE LONG-AXIS XRAY IS AVAILABLE. THE QUALITY IS RATHER LOW, BUT IT APPEARS THAT THE ALIGNMENT IS SUBOPTIMAL. THERE IS NO INDICATION AS TO THE POSSIBLE CAUSE OF THIS PARTICULAR COMPONENT ORIENTATION. HENCE, THERE ARE NO APPARENT REASONS TO INITIATE A PRODUCT ACTION. THE ROOT CAUSE FOR THE FAILURE, IN ABSENCE OF FURTHER INFORMATION, SHOULD BE ASCRIBED TO POOR ALIGNMENT OF THE COMPONENTS. ON 01 DEC 2015 IT WAS COMMUNICATED THAT A VISIT WAS PLANNED FOR THIS DATE AND THE REVISION WILL BE DISCUSSED BETWEEN SURGEON AND PATIENT; SO, IT IS NOT YET PERFORMED AT THIS STAGE. BATCH REVIEW PERFORMED ON 02 DECEMBER 2015: LOT 132243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 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 ISSUE. GMK PRIMARY TIBIAL TRAY FIXED CEMENTED # 3 R CODE 02.07.1203R LOT. 146433 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 DECEMBER 2014. EXPIRATION DATE: 2019-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK PRIMARY TIBIAL INSERT PS FIXED # 3/10MM CODE 02.07.0310PSF LOT. 136091 ((B)(4)): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 FEBRUARY 2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 FROM THE INITIAL REPORTER AND INCLUDES: "THE PATIENT WANTED A REVISION, BUT I DON'T KNOW IF THE SURGERY HAS BEEN DONE OR NOT. IF YES, PROBABLY FROM ANOTHER SURGEON." ON 29 JANUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION NECESSARY BECAUSE OF INNCORECT POSITIONING OF IMPLANTS (5ࠉN VALGUS). THE REVISION DATE IS UNKNOWN AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791045 GMK PS CEMENTED FEMUR SIZE 3 RIGHT CEMENTED PS FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 132243

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other