BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L

    MDR report key: 7536832 · Received May 23, 2018

    Report

    Report Number
    3005180920-2018-00353
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 23, 2018
    Report Date
    July 25, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819346
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018 WE WERE INFORMED THAT SPACER REVISED ON (B)(6).

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 MAY 2018; LOT 160072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2016. EXPIRATION DATE: 2021-02-28; 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. OTHERS DEVICES INVOLVED: GMK-REVISION FEMUR REVISION PS #3 L REFERENCE 02.07.2403L (K102437); LOT 156011: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JANUARY 2016. EXPIRATION DATE: 2020-11-17. 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 # 3 REFERENCE 02.07.0035RP (K090988); LOT 141003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 APRIL 2014. EXPIRATION DATE: 2019-03-31 N;O ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FIXED TIBIAL INSERT SC # 2/12MM REFERENCE 02.07.0212SCF (K103170); LOT 132526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT GMK-REVISION OFFSET CONNECTOR 3 MM REFERENCE 02.07.0003 (K102437); LOT 162576: (B)(4) 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 2 SIMILAR REPORTED EVENTS. GMK-REVISION TIBIAL AUGMENTATION # 2/5MM REFERENCE 02.09.TA205 (K130299); LOT 123237: (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 SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION TIBIAL AUGMENTATION # 2/5MM REFERENCE 02.09.TA205 (K130299); LOT 153067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED. GMK-REVISION FEMORAL WEDGE POSTERIOR # 3/5MM REFERENCE 02.05.03PW (K102437); LOT 134634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2013. EXPIRATION DATE: 2018-09-30; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT (2 ITEMS OF THIS LOT INVOLVED IN THIS COMPLAINT). GMK-REVISION EXTENSION STEM - FLUTED Ø 15 L 105 REFERENCE 02.07.FCL15105 (K120790); LOT 154997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 DECEMBER 2015. EXPIRATION DATE: 2020-11-17; 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 - CEMENTED Ø 13 L 65 REFERENCE 02.07.FSC13065 (K120790); LOT 155884: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 NOVEMBER 2016. EXPIRATION DATE: 2021-01-13; 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 YEAR AND 3 MONTHS AFTER THE PRIMARY. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON REVISED ALL HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378519 GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L REVISION FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 160072 07630030819346

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention