MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0412FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary knee surgery on (b)(6) 2010.On (b)(6) 2020, the patient came in reporting instability due to a loose patella and tibia.The surgeon revised the femoral component, tibial tray, insert, and patella and added an extension stem and cone.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain and the cause is unknown.The surgeon opened the patient and found no implants to be loose.He revised the poly (with one of the same thickness; no instability reported) and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 june 2023.Lot 183059: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-jul-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 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: 17348647
• Report Number: 3005180920-2023-00529
• Device Sequence Number: 17409684
• Product Code: JWH
• UDI-Device Identifier: 07630030826580
• UDI-Public: 07630030826580
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/19/2023

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: 07/15/2023
• Device Model Number: 02.12.0412FR
• Device Catalogue Number: 02.12.0412FR
• Device Lot Number: 183059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2018
• 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: Female