MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 10MM

Model Number	02.12.E0510FR
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	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain and cause is unknown.The surgeon determined the patient had a slight flexion contracture.At about 1 year and 11 months post primary the surgeon upsized the poly, revised the liner from a 10mm to an 11mm while removing posterior osteophytes.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 14 october 2025: gmk-sphere 02.12.E0510fr gmk-sphere tibial insert e-cross - flex 5r - 10mm (k202022) lot 2310265: (b)(4) items manufactured and released on 02-jun-2023.Expiration date: 2028-05-21.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.Gmk-sphere 02.15.E035 moto patella e-cross ø35 (k213071) lot 2238173: (b)(4) items manufactured and released on 10-nov-2022.Expiration date: 2027-10-27.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.Conclusions: the surgeon revised liner and removed some osteophytes, to restore the joint from flexion contracture, stifness.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 5R - 10MM
• 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: 23436205
• Report Number: 3005180920-2025-01048
• Device Sequence Number: 8625423
• Product Code: JWH
• UDI-Device Identifier: 07630971262003
• UDI-Public: 07630971262003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 10/31/2025

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.E0510FR
• Device Lot Number: 2310265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2023
• 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 Sex: Male