MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0210FL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 3 months after the primary surgery, the patient has been revised because of instability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01-jul-2022.Lot 176145: (b)(4) items manufactured and released on 29-dec-2017.Expiration date: 2022-12-11.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 the review.Clinical evaluation performed by medical affairs director: 2 years after primary cemented tka, developmental instability makes revision advisable and a more constrained type of implant is chosen.Progressive ligament loosening is a possible form of disease progression.In this case, a collateral ligament was damaged, and therefore the existing prosthesis was no longer indicated.This revision is not caused by a defective implant.

• Brand Name: GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15063297
• Report Number: 3005180920-2022-00530
• Device Sequence Number: 5557590
• Product Code: JWH
• UDI-Device Identifier: 07630030826139
• UDI-Public: 07630030826139
• 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: 2020
• Device Explanted Year: 2022
• 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): 07/20/2022

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: 12/11/2022
• Device Model Number: 02.12.0210FL
• Device Catalogue Number: 02.12.0210FL
• Device Lot Number: 176145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2017
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 76 KG