BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM

    MDR report key: 16415687 · Received February 22, 2023

    Report

    Report Number
    3005180920-2023-00061
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816710
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT ABOUT 3 YEARS AFTER TOTAL KNEE REVISION SURGERY, THE LIGAMENTS DEVELOP INSTABILITY AND THE SURGEON DECIDES THAT A CONSTRAINED PROSTHESIS IS CALLED FOR. THE REASON FOR THIS EXCHANGE OF DEVICES IS DISEASE PROGRESSION AND IT DOES NOT APPEAR TO BE RELATED TO A POORLY WORKING DEVICE. BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 171350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2017. EXPIRATION DATE: 2022-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER COMPONENTS INVOLVED IN THE EVENT: GMK-REVISION 02.07.2402R FEMUR REVISION PS SIZE 2 R (K102437) LOT 110159A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2016 AND 02-SEP-2016 AND 04-NOV-2016. EXPIRATION DATE: 2021-04-21 AND 2021-08-21 AND 2021-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT FATHER AND RESTERILIZED 110159: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2011. EXPIRATION DATE: 2016-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.FCL16065 EXTENSION STEM - FLUTED Ø 16 L 65 (K120790) LOT 185138: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2018. EXPIRATION DATE: 2023-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0003 OFFSET CONNECTOR 3 MM (K102437) LOT 1904831: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2019. EXPIRATION DATE: 2024-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.FCL22065 EXTENSION STEM - FLUTED Ø 22 L 65 (K120790) LOT. 115739C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2018. EXPIRATION DATE: 2023-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT FATHER AND RESTERILIZED 115739: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2012. EXPIRATION DATE: 2017-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.0682R REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT. 164179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2016. EXPIRATION DATE: 2021-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO MEDIAL AND LATERAL LIGAMENT INSTABILITY. THE SURGEON REVISED SUCCESSFULLY THE GMK REVISION SYSTEM AND IMPLANTED GMK HINGE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228316 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM KNEE SEMICONSTRAINED INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0214SCF 171350 07630030816710

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention