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

Model Number	02.12.0210FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 april 2023.Lot 2005719: (b)(4) items manufactured and released on 11-aug-2020.Expiration date: 2025-07-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision surgery of a gmk sphere implant after 10 months from primary implantation due to discomfort and flexion contracture.In the revision surgery, the tibial insert and the tibial tray have been replaced.A picture of the explanted liner has been sent for investigation.From this picture, we can't identify any anomalies or elements that can be considered relevant for the event.There is no evidence that the event is related to a faulty device.Additional involved implant.Batch review performed on 21 april 2023 on gmk-sphere 02.07.2802l tibial tray fixed cemented size 2 l tinbn coated (k202684) lot.2007330 lot 2007330: (b)(4) items manufactured and released on 18-jan-2021.Expiration date: 2026-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 10 months after the primary, the patient came in reporting discomfort due to a flexion contracture and the cause of the flexion contracture is unknown.The surgeon revised the insert and tibial tray.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 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, 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: 16960187
• Report Number: 3005180920-2023-00348
• Device Sequence Number: 5224879
• Product Code: JWH
• UDI-Device Identifier: 07630030826139
• UDI-Public: 07630030826139
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/19/2023

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: 07/28/2025
• Device Model Number: 02.12.0210FL
• Device Catalogue Number: 02.12.0210FL
• Device Lot Number: 2005719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• 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: Unknown