MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 20MM

Model Number	02.12.E0320FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain after dislocating the knee when bending down to tie his shoe.About 3 days after primary the surgeon revised all components to hinge components.During the revision the liner was found detached from the tibial tray, this was due to a close reduction of the knee causing this disassembly.The surgery was completed successfully.During the primary a 20mm was implanted because the patient had a very lax knee.
Additional Manufacturer Narrative
Batch review performed on 17 july 2025: lot 2245442: (b)(4) items manufactured and released on 10-feb-2023.Expiration date: 2028-01-27.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.Additional components revised: gmk-spherika 02.12.Ka13r femoral component spherika cemented s3+r (k211004) lot 2432500: (b)(4) items manufactured and released on 03-feb-2025.Expiration date: 2030-01-14.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.Gmk-spherika 02.12.T4i3r gmk-sphere tibial component cemented t4i3r (k121416) lot 2315347: (b)(4) items manufactured and released on 19-oct-2023.Expiration date: 2028-09-28.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
Visual inspection: revision surgery of a gmk spherika implant was performed due to anterior femoral luxation and bearing dislocation.The explanted components were visually inspected upon return for investigation.No anomalies were identified on the implants that could have contributed to the event.The anterior luxation of the femoral component over the tibial baseplate occurred when the patient flexed the knee to tie their shoes.This was likely caused by progressively increasing joint laxity reported by the patient following the primary surgery.The luxation subsequently led to abnormal loading on the liner, resulting in dislocation of the bearing from the baseplate.Based on the visual inspection, there is no evidence to suggest that the event was caused by a manufacturing defect or device malfunction.Device evaluation: - d9 - h3.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 3R - 20MM
• 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: 22607934
• Report Number: 3005180920-2025-00712
• Device Sequence Number: 9603682
• Product Code: JWH
• UDI-Device Identifier: 07630971261723
• UDI-Public: 07630971261723
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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.E0320FR
• Device Lot Number: 2245442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 73 KG