BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 4 RIGHT

    MDR report key: 5935404 · Received September 8, 2016

    Report

    Report Number
    3005180920-2016-00460
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    June 7, 2016
    Report Date
    September 8, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 05 SEPTEMBER 2016. LOT 141906: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2014. EXPIRATION DATE: 2019-03-31. 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-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM, CODE 02.07.0414SCF, LOT. 140481 (K103170). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE LOT (MDR 2015-00278). GMK-REVISION, REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 RIGHT, CODE 02.07.0684R, LOT. 122885 (K123721). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2012. EXPIRATION DATE: 2017-09-30. 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-REVISION FEMORAL WEDGE POSTERIOR SIZE 4/10MM, CODE 02.07.410FPW, LOT. 082559/T (K102437). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2014. EXPIRATION DATE: 2018-11-30. 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-REVISION EXTENSION STEM - FLUTED Ø 16 L 150, CODE 02.07.FCL16150, LOT. 143683 (K120790). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JULY 2014. EXPIRATION DATE: 2019-05-31. 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-REVISION EXTENSION STEM - FLUTED Ø 16 L 65, CODE 02.07.FCL16065, LOT. 115721 (K120790). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 AUGUST 2012. EXPIRATION DATE: 2017-06-30. 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-REVISION PATELLA RESURFACING SIZE 3, CODE 02.07.0035RP, LOT. 148620 (K090988). APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MARCH 2015. EXPIRATION DATE: 2020-01-31. 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-REVISION OFFSET CONNECTOR 3 MM, CODE 02.07.0003, LOT. 140441 (K102437): 2 ITEMS INVOLVED. APPROX (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 05 SEPTEMBER 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS INITIAL REPORT. ON 06 SEPTEMBER 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. ON (B)(6) 2016 THE SURGEON REMOVED THE FEMUR, TIBIAL TRAY, TIBIAL INSERT, FEMORAL WEDGE, EXTENSION STEM, CEMENTLESS EXTENSION STEM AND RESURFACING PATELLA. THE SURGEON IMPLANTED AN ANTIBIOTIC SPACER. ON (B)(6) 2016 THE SURGEON COMPLETED THE REVISION WITH PERMANENT IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587572 GMK-REVISION FEMUR REVISION PS SIZE 4 RIGHT KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 141906

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention