BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS #4 R

    MDR report key: 12353526 · Received August 23, 2021

    Report

    Report Number
    3005180920-2021-00678
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 23, 2021
    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 · 1

    BATCH REVIEWS PERFORMED ON 04.AUG.2021: LOT 1810569: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-MARCH-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. OTHER COMPONENTS INVOLVED: GMK-REVISION 02.07.0683R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 R LOT. 186398 K123721 LOT 186398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2018. EXPIRATION DATE: 2023-OCT-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM LOT. 189532 K103170. LOT 189532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-MARCH-2019. EXPIRATION DATE: 2024-FEB-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM LOT. 1900664 K102437. LOT 1900664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-MARCH-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL22065 EXTENSION STEM - FLUTED Ø 22 L 65 LOT. 189595 K120790. LOT 189595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2019. EXPIRATION DATE: 2024-FEB-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.07.FCL18065 EXTENSION STEM - FLUTED Ø 18 L 65 LOT. 1810602 K120790. LOT 1810602: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-FEB-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.07.0034RP PATELLA RESURFACING SIZE 2 LOT. 1810561 K090988. LOT 1810561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 1-MARCH-2019. EXPIRATION DATE: 2024-FEB-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. GMK-REVISION 02.09.TA305 TIBIAL AUGMENTATION SIZE 3/5MM LOT. 189435 K130299. LOT 189435: 56 ITEMS MANUFACTURED AND RELEASED ON 28-MARCH-2019. EXPIRATION DATE: 2024-MARCH-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT (2 PIECES OF THE SAME LOT REPORTED IN THIS COMPLAINT).

    Description of Event or Problem · 1

    2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THIS PATIENT WAS IMPLANTED WITH COMPETITOR IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250560 GMK-REVISION FEMUR REVISION PS #4 R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2404R 1810569 07630030821431

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention