MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0514SCF FIXED TIBIAL INSERT SC SIZE 5/14MM; KNEE FIXED TIBIAL INSERT

Model Number	02.07.0514SCF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 6 years and 9 months after the primary surgery, the patient came in reporting pain after falling.When the surgeon opened the patient up, the poly popped right out.The surgeon revised the poly and the surgery was completed successfully.The patient was previously revised from competitor's components to gmk revision system.
Additional Manufacturer Narrative
Batch review performed on 7 march 2023.Lot 154973: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-aug-23.No anomalies found related to the problem.To date, 7 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 7 years after revision tka, following a traumatic event the polyethylene insert is unclipped from the baseplate.Normally, the metal reinforcement plug should be screwed to the tibial baseplate with a controlled torque, that is supposed to prevent self-unscrewing.Even if the plug had not been fully fixed to the baseplate at index surgery, it may have worked correctly for 7 years until a fall caused the insert to unclip itself.At revision, only the insert is replaced to a new one, as the other components were still functioning properly.

• Brand Name: GMK-REVISION 02.07.0514SCF FIXED TIBIAL INSERT SC SIZE 5/14MM
• Common Device Name: KNEE FIXED TIBIAL 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: 16644030
• Report Number: 3005180920-2023-00188
• Device Sequence Number: 17681549
• Product Code: JWH
• UDI-Device Identifier: 07630030818455
• UDI-Public: 07630030818455
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/30/2023

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: 09/23/2015
• Device Model Number: 02.07.0514SCF
• Device Catalogue Number: 02.07.0514SCF
• Device Lot Number: 154973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2015
• 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