BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE4 L

    MDR report key: 9749832 · Received February 25, 2020

    Report

    Report Number
    3005180920-2020-00101
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821424
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 154241: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2015. EXPIRATION DATE: 2020-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. OTHER DEVICES INVOLVED IN THE EVENT: GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L LOT. 150586 (K123721). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 150586: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2015. EXPIRATION DATE: 2020-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.0417SCF FIXED TIBIAL INSERT SC SIZE 4/17MM LOT. 145730 (K103170). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 145730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 161544 (K090988). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 161544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2016. EXPIRATION DATE: 2021-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM LOT. 160317 (K102437). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 160317: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2016. EXPIRATION DATE: 2021-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0005 OFFSET CONNECTOR 5 MM LOT. 155008 (K102437). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 155008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2015. EXPIRATION DATE: 2020-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.FCL15105 EXTENSION STEM - FLUTED 15 L 105 LOT. 154997 (K120790). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 154997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-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 WITH ANOTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.07.FCL14065 EXTENSION STEM - FLUTED 14 L 65 LOT. 136389 (K1207909). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 136389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. GMK-REVISION 02.09.TA410 TIBIAL AUGMENTATION SIZE 4/10MM LOT. 123246A (K130299). BATCH REVIEW PERFORMED ON 16 FEBRUARY 2020: LOT 123246A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.

    Description of Event or Problem · 1

    REVISION SURGERY AFTER 3 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGERY REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT HAD TWO REVISIONS DUE TO AN INFECTION. DURING THE FIRST THE INLAY WAS CHANGED, DURING THE SECOND ALL THE HARDWARE WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213917 GMK-REVISION FEMUR REVISION PS SIZE4 L REVISION FEMUR PS JWH MEDACTA INTERNATIONAL SA 02.07.2404L 154241 07630030821424

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention