BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PS TIBIAL INSERT SIZE 3 / 17 MM

    MDR report key: 4848093 · Received June 11, 2015

    Report

    Report Number
    3005180920-2015-00115
    Event Type
    Injury
    Date Received
    June 11, 2015
    Report Date
    September 24, 2015
    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

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 114227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2012. 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 FIXED TIBIA CODE 1203L LOT 145585 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2014. EXPIRATION DATE: 08/31/2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORT ISSUE. GMK CEMENTED FEMUR CODE 02.07.2214L LOT 140919 *K122232) 25 ITEMS PRODUCED AND RELEASED ON (B)(4) /2014. EXPIRATION DATE: 02/28/2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK RESURFACING PATELLA CODE 02.07.0033RP LOT 143623 (K090988): (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(4) 2014. EXPIRATION DATE 07/31/2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON (B)(4) 2015 IT WAS CONFIRMED THAT THE EXPLANTS WILL NOT BE AVAILABLE. ANALYSIS MADE BY MEDICAL AFFAIRS DIRECTOR ON (B)(4) 2015: ONLY A LIMITED VIEW XRAY IS AVAILABLE. FROM THAT, THE KNEE APPEARS TO HAVE BEEN IMPLANTED WITH A SIGNIFICANT RESIDUAL VALGUS ORIENTATION, I DO NOT KNOW THE REASONS FOR THIS CHOICE. IT IS CERTAINLY A MECHANICALLY DEMANDING CONDITION FOR THE PROSTHESIS AND MAY WELL BE THE REASON FOR PT REPORTED PAIN AND DISCOMFORT. ALSO TIBIA RESECTION HAD TO BE PERFORMED RATHER LOW AND A HIGH INSERT WAS EMPLOYED, WHICH IN SUCH VALGUS ORIENTATION MAY INCREASE THE OUT-OF-AXIS STRESSES AND ADD TO PT DISCOMFORT. IT IS PLAUSIBLE THAT THE ROOT CAUSE FOR REVISION WAS CHALLENGING ALIGNMENT SITUATION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 A MY KNEE PLANNING REVIEW WAS PERFORMED; A SHORT SUMMARY OF THIS ANALYSIS IS REPORTED HERE BELOW: ALL THE STEPS OF THE PLANNING WERE RE-CHECKED AN NO ANOMALY WAS FOUND IN ANY OF THEM; MOREOVER, THEY MADE A POST-OP ANALYSIS CONCERNING THE FEMUR COMPONENT (COMPLAINT'S OBJECT): THEY OVERLAPPED THE 3D BONE MODEL OF THE FEMUR AND THE X-RAYS RECEIVED. IT WAS FOUND OUT THAT THE PROSTHESIS HAS BEEN IMPLANTED IN ABOUT 3° OF VALGUS RESPECT THE PLANNING. IT WAS UNDERLINED THAT THE X-RAY IS NOT EXACTLY FRONTAL; SO THE VALUE COULD NOT BE TOTALLY PRECISE. CONCERNING THE OTHER X-RAY, THEY COULDN'T USE IT TO OBTAIN ANY SIGNIFICANT VALUE BECAUSE IT DOES NOT SHOWN A SAGITTAL VIEW (THE LEG IS ROTATED). ON 23 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380791 GMK PS TIBIAL INSERT SIZE 3 / 17 MM UHMWPE KNEE PS TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention