BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED SIZE 5 NARROW / RIGHT STD

    MDR report key: 5775146 · Received July 7, 2016

    Report

    Report Number
    3005180920-2016-00329
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    June 7, 2016
    Report Date
    July 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 JULY 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: PRIMARY TKA WAS PERFORMED USING A 20MM INSERT. WE HAVE NO INFORMATION AVAILABLE SUCH AS DIAGNOSIS OR XRAYS. NORMALLY, WHEN SUCH A THICK INSERT IS CHOSEN, THE JOINT IS SERIOUSLY COMPROMISED AND MAYBE THE CHOICE OF A UC INSERT WAS AN ATTEMPT BY THE SURGEON TO AVOID A CONSTRAINED KNEE, FUNCTIONALLY LESS PERFORMING BUT OF COURSE MORE STABLE. IT IS RATHER POSSIBLE THAT A CASE REQUIRING A 20MM INSERT MAY SOON END UP REQUIRING A CONSTRAINED PROSTHESIS. THERE IS THEREFORE NO REASON TO SUSPECT THAT THE CAUSE OF INSTABILITY DERIVES FROM A FAULTY IMPLANT. BATCH REVIEWS PERFORMED ON 05 JULY 2016. LOT 153805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2015. EXPIRATION DATE: 2020-07-31. 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 TRAY FIXED CEMENTED SIZE 4 RGIHT, 02.07.1204R, LOT. 153496 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. 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 4 / 20 MM, CODE 02.07.0420FUC, LOT. 133337 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. 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. ON 05 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION INCLUDED INTO THIS REPORT. ON 06 JULY 2016 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO INSTABILITY. THE SURGEON REVISED THE GMK TIBIAL TRAY, GMK FEMUR AND THE 20MM UC INSERT. THE SURGEON REVISED WITH A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428614 GMK-PRIMARY FEMUR CEMENTED SIZE 5 NARROW / RIGHT STD FEMUR CEMENTED JWH MEDACTA INTERNATIONAL SA 153805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention