MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM; KNEE SEMICONSTRAINED INSERT

Model Number	02.07.0214SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM
• Common Device Name: KNEE SEMICONSTRAINED INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16415687
• Report Number: 3005180920-2023-00061
• Device Sequence Number: 14888655
• Product Code: JWH
• UDI-Device Identifier: 07630030816710
• UDI-Public: 07630030816710
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: 02.07.0214SCF
• Device Catalogue Number: 02.07.0214SCF
• Device Lot Number: 171350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male