MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM; KNEE TIVIAL INSERT

Model Number	02.07.0326SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years and 3 months after the previous revision surgery due to instability, the patient came in reporting instability and the cause is unknown.The surgeon revised all components to gmk hinge.The patient had already underwent to different surgeries due to multiple infections.
Additional Manufacturer Narrative
Batch review performed on 28-jun-2023.Lot 171527: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-02-06.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.Additional components involved: batch review performed on 28-jun-2023.Gmk-revision 02.07.2404r femur revision ps size 4 r (k102437) lot.163514: (b)(4) items manufactured and released on 28-jun-2016.Expiration date: 2021-06-14.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 02.07.0683r revision fixed tibial tray cemented size 3 r (k123721) lot.160309: (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 sold with no similar reported case during the period of the review.Gmk-revision 02.07.0036rp patella resurfacing size 4 (k113571) lot.148622: (b)(4) items manufactured and released on 25-feb-2015.Expiration date: 2020-01-31.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.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM
• Common Device Name: KNEE TIVIAL 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17325436
• Report Number: 3005180920-2023-00536
• Device Sequence Number: 6319686
• Product Code: JWH
• UDI-Device Identifier: 07630030817564
• UDI-Public: 07630030817564
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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: 02/06/2022
• Device Model Number: 02.07.0326SCF
• Device Catalogue Number: 02.07.0326SCF
• Device Lot Number: 171527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2017
• 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 Sex: Male