BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK FIXED PS LINER SIZE 6/ 10MM

    MDR report key: 4391198 · Received December 29, 2014

    Report

    Report Number
    3005180920-2014-00194
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW PERFORMED ON FEBRUARY 17, 2015. GMK PRIMARY FIXED PE POSTERO STABILIZED TIBIAL INSERT SIZE 6, 10 MM: CODE 02.07.061OPSF / LOT 121924 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH SPECS VALID AT THE TIME OF MANUFACTURING; (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. IN THE INITIAL MDR, IT WAS ALREADY REPORTED THE REVIEW OF THE LOT 114238, THAT WAS THE INITIAL LINER IMPLANTED ON (B)(6) 2012 AND REVISED ON (B)(6) 2014 DUE TO THE LACK OF EXTENSION. WE RECEIVED BACK THE PART OF THE SCREW THAT WAS ANALYZED ON 01/15/2015 BY R&D, EVEN IF IT WAS UNCLEAR THAT THE LOT OF THE ITEM WAS NOT CORRECT INFO RECEIVED FROM (B)(6) 2015 ON): THE SCREW BROKE AT THE BASE OF THE THREAD LIKELY DUE TO AN OVER TORSION. FROM A VISUAL INSPECTION, THE SCREW DOES NOT SHOW DEFECTS. ON 02/09/2015 THE RETRIEVED PART OF THE SCREW HAS BEEN MEASURED IN OUR CQ DEPARTMENT WITHOUT FINDING ANY DIMENSIONAL DEFECT.

    Additional Manufacturer Narrative · 1

    ON JULY 13, 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND IN THE FIRST AND SECOND FOLLOW UPS. ON JULY 27, 2015, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) IT WAS CONFIRMED THAT NO X-RAY WILL BE AVAILABLE AND THAT NO ITEMS WILL BE SENT BACK FOR ANALYSIS. ON APRIL 29, 2015 THE MEDICAL AFFAIRS STATED THAT THERE IS NO SUFFICIENT INFORMATION TO DRAW CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY FIXED PE POSTERO STABILIZED TIBIAL INSERT SIZE 6, 10 MM: CODE 02.07.0610PSF / LOT # 114238 (24 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS VALID AT THE TIME OF MFG. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    DURING THE INITIAL REPORT, IT WAS REPORTED THAT: REVISION SURGERY 2 YEARS AFTER PRIMARY DUE TO LACK OF EXTENSION 10-15." THE SCREW OF THE INLAY WAS FOUND TO BE BROKEN AND IT WAS CHANGED. ON (B)(6) 2015, WE STARTED RECEIVING CLEARER AND MORE PRECISE INFORMATION ABOUT THE CASE: THE PRIMARY SURGERY TOOK PLACE IN 2008 WITH IMPLANTS OF ANOTHER COMPANY. THEN THE FIRST REVISION TOOK PLACE ON (B)(6) 2012 (THIS TIME WITH MEDACTA PRODUCTS THAT REPLACED THE IMPLANTS OF THE OTHER COMPANY). FINALLY, THE SECOND AND LAST REVISION TOOK PLACE ON (B)(6) 2014 - DUE TO THE LACK OF EXTENSION. THE LINER HAS BEEN REMOVED AND REPLACED WITH ANOTHER LINER OF THE SAME SIZE. DURING THAT REPLACEMENT, THE PS SCREW OF THE NEW LINER BROKE AND THE THREAD REMAINED IN THE TIBIA PLATEAU, WHILE THE HEAD OF THE SCREW WAS REMOVED; THE INLAY IS ONLY FIXED WITH THE CLIPPING MECHANISM.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854734 GMK FIXED PS LINER SIZE 6/ 10MM FIXED PE POSTERO STAB TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1