BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 5 R

    MDR report key: 7486990 · Received May 4, 2018

    Report

    Report Number
    3005180920-2018-00298
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 6, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821455
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 MAY 2018; LOT 162496: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MAY 2016. EXPIRATION DATE:2021-05-05 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHERS DEVICES INVOLVED: GMK-REVISION REFERENCE 02.07.0412SCF FIXED TIBIAL INSERT SC SIZE 4/12MM; LOT 165093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2016. EXPIRATION DATE:2021-09-27; 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 REFERENCE 02.07.0684R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R; LOT 164180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-20; 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 REFERENCE 02.07.FCL22105 EXTENSION STEM - FLUTED Ø 22 L 105; LOT 161797: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2016. EXPIRATION DATE: 2021-04-25; 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 REFERENCE 02.05.05DW FEMORAL WEDGE DISTAL SIZE 5/8MM; LOT 162598: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JUNE 2016. EXPIRATION DATE: 2021-06-08. 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 (2 PIECES OF THIS LOT INVOLVED IN THIS COMPLAINT). GMK-REVISION REFERENCE 02.07.0003 OFFSET CONNECTOR 3 MM; LOT 162576: 110 ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-06-20 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT GMK-REVISION REFERENCE 02.09.TA305 TIBIAL AUGMENTATION SIZE 3/5MM; LOT 165138: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 SEPTEMBER 2016. EXPIRATION DATE: 2021-09-01; 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 REFERENCE 02.07.FCL20105 EXTENSION STEM - FLUTED Ø 20 L 105; LOT 167145: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JANUARY 2017. EXPIRATION DATE: 2022-01-18; 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.

    Description of Event or Problem · 1

    ONE YEAR AFTER PRIMARY THE PATIENT HAD A KNEE INFECTION. THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED A SPACER. LATER, ON THE (B)(6) 2018 SWAPPED THE SPACER WITH DEFINITIVE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329438 GMK-REVISION FEMUR REVISION PS SIZE 5 R FEMUR JWH MEDACTA INTERNATIONAL SA 162496 07630030821455

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention