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

Model Number	02.12.0410FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient underwent primary surgery with implantation of gmk-sphere components without resurfacing patella.On (b)(6) 2025, the patient came in and staphylococcus epidermidis infection is suspected.Wound with drainage up to the prosthesis.No loosening of the components.The surgeon revised successfully the tibial insert.
Additional Manufacturer Narrative
Batch review performed on 19-feb-2025.Lot 2423916: (b)(4) items manufactured and released on 08-oct-2024.Expiration date: 20-sep-2029.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.Analysis performed by r&d manager: two months following the primary surgery, the surgeon performed a debridement and poly swap procedure to address a suspected infection.The available picture shows the tibial insert covered by body fluids, with some scratches resulting from attempts to revise the existing liner.No signs of implant failure have been identified by the surgeon.Based on the available information, it can be concluded that the root cause of the complaint is not related to a faulty device.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
• 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: 21606146
• Report Number: 3005180920-2025-00156
• Device Sequence Number: 9275362
• 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: 2024
• Device Explanted Year: 2025
• 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): 03/14/2025

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 Model Number: 02.12.0410FR
• Device Lot Number: 2423916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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