MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0410FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 6 months after the primary surgery, the patient came reporting anterior pain and instability of the right knee.No infection.No loosening of the implants.The surgeon revised successfully the insert (10mm) with a thicker one (11mm).
Additional Manufacturer Narrative
Batch review performed on 28-apr-2023.Lot 2108902: (b)(4) manufactured and released on 14-sep-2021.Expiration date: 2026-08-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs director: secondary patella resurfacing 1,5 years after primary cemented tka.During the second surgery, as customary, the tibial insert was replaced to a new one, but there was no problem with the existing implants.Root cause: disease progression, no problems with the devices.Preliminary analysis performed by r&d manager: tka 1 year and half after primary cemented tka due to anterior knee pain and instability.During the second surgery the tibial insert has been replaced with a thicker one.No problem with the existing implants has been reported.Based on the picture of the explanted insert, some scratches can be observed in the anterior side of the insert, probably generated in the attempt of removing the implanted device.Some lines seem to be present on the posterior aspect of the insert as well, but they are not well clear on the picture at hand.Based on the available information it's not possible to suspect that the root cause of the problem is a faulty device.

• Brand Name: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: 16992798
• Report Number: 3005180920-2023-00365
• Device Sequence Number: 7039838
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/24/2023

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: 08/26/2026
• Device Model Number: 02.12.0410FR
• Device Catalogue Number: 02.12.0410FR
• Device Lot Number: 2108902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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: 68 YR
• Patient Sex: Male