BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 4 R

    MDR report key: 9382049 · Received November 27, 2019

    Report

    Report Number
    3005180920-2019-01010
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 4, 2019
    Report Date
    April 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821431
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE (B)(6) 2020, WE WERE INFORMED THAT THE PATIENT HAD PERMANENT HARDWARE IMPLANTED ON THE (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 135884: 15 ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2013. EXPIRATION DATE: 2018-OCT-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.1204R FIXED TIBIAL TRAY CEMENTED SIZE 4 R (K090988) LOT. 136136. BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 136136: 32 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2014. EXPIRATION DATE: 2019-JAN-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.0412SCF FIXED TIBIAL INSERT SC SIZE 4/12MM (K103170) LOT. 121807. BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 121807: 25 ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2012. EXPIRATION DATE: 2017-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 136083 BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 136083: 240ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2014. EXPIRATION DATE: 2018-DEC-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 239 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.FCL15150 EXTENSION STEM - FLUTED Ø 15 L 150 (K120790) LOT. 115719. BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 115719: 40 ITEMS MANUFACTURED AND RELEASED ON 24-AGO-2012. EXPIRATION DATE: 2017-JUNE-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.FCL13105 EXTENSION STEM FLUTED Ø 13 L 105 (K120790) LOT. 131538. BATCH REVIEW PERFORMED ON 14 NOVEMBER 2019: LOT 131538: 15 ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2013. EXPIRATION DATE: 2018-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 14 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 5 YEARS AFTER MEDACTA IMPLANT INSERTION THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178931 GMK-REVISION FEMUR REVISION PS SIZE 4 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2404R 135884 07630030821431

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention