MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 6+R

Model Number	02.12.0026R
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 9 years and 4 months from primary due to pain and stiffness, causing sagittal instability.The surgeon removed the scar tissue and revised the gmk-sphere femoral component, insert, and tibial tray to a gmk-hinge femoral component, insert, and tibial tray.The surgery was completed successfully.It has been reported that there were signs of lysis on the polyethylene liner.It has been hypothesized that the instability have caused tibial subsidence and successive lysis of the wear.
Additional Manufacturer Narrative
No devices or pictures received.Batch review performed on 19 june 2026: gmk-sphere 02.12.0026r gmk-sphere femoral component cemented - 6+r (k140826) lot 144571: (b)(4) manufactured and released on 01-apr-2025.Expiration date: 16-mar-2030.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0511fr gmk-sphere tibial insert - flex s5r - 11 mm (k140826) lot 160777: (b)(4) manufactured and released on 25-05-2016.Expiration date: 09-may-2021.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.1205r tibial tray fix cemented s.5r (k090988) lot 162465: (b)(4) manufactured and released on 17-jun-2016.Expiration date: 01-jun-2021.No anomalies found related to the problem.To date, all the 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.Signs of lysis on the polyethylene liner were reported, and it was hypothesized that instability may have contributed to tibial subsidence and subsequent wear-related lysis; however, the involved devices and pictures were not received, and the investigation was therefore limited.The device history record reviews for the involved lots did not indicate any potentially related manufacturing issue, and no similar events were identified for the reviewed sold items of the same lots.Based on the available information, no device-related root cause can be confirmed.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 6+R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25608881
• Report Number: 3005180920-2026-00593
• Device Sequence Number: 18620480
• Product Code: JWH
• UDI-Device Identifier: 07630030862441
• UDI-Public: 07630030862441
• Combination Product (Y/N): N
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 06/30/2019
• Device Model Number: 02.12.0026R
• Device Lot Number: 144571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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