BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

    MDR report key: 8945082 · Received August 29, 2019

    Report

    Report Number
    3005180920-2019-00713
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819360
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 AUGUST 2019: LOT 163519: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-06-12. 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. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 8 AUGUST 2019: GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM (K102437) LOT. 172194. LOT 172194: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT GMK-REVISION 02.07.FCL14105 EXTENSION STEM - FLUTED Ø 14 L 105 (K120790) LOT. 162542. LOT 162542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2016. EXPIRATION DATE: 2021-07-27. 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 02.07.0310PSF TIBIAL INSERT PS FIXED # 3/10MM (K090988) LOT. 167467. LOT 167467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 FEBRUARY 2017. EXPIRATION DATE: 2022-01-22. 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 02.09.TA305 TIBIAL AUGMENTATION # 3/5MM (K130299) LOT. 155947. LOT 155947: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 DECEMBER 2015. EXPIRATION DATE: 2020-11-21. 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 02.07.CS20 CONO TIBIALE 3D METAL CENTRATO S H20 (K170149) LOT. 163587. LOT 163587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2016. EXPIRATION DATE: 2021-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2019 WE RECEIVED THE INFORMATION OF A REVISION SURGERY, THAT WAS THEN PERFORMED ON (B)(6) 2019, DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL IMPLANTS FROM THE PATIENT AND IMPLANTED AN ANTIBIOTIC SPACER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741670 GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 163519 07630030819360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention