MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 10MM

Model Number	02.12.E0410FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient came in presenting pain due to failing competitor`s sutures in quad which resulted in patella tracking issues.There was no indication of trauma.The surgeon addressed the sutures, performed a washout and revised the flex 4l - 10mm insert to a flex 4l - 11mm insert to improve the stability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 june 2026 gmk-spherika 02.12.E0410fl gmk-sphere tibial insert e-cross - flex 4l - 10mm (k202022) lot.2523345: (b)(4) items manufactured and released on 09-oct-2025.Expiration date: 2030-09-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-spherika 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3 lot.2518412 (k202022) lot 2518412: (b)(4) items manufactured and released on 17-sep-2025.Expiration date: 2030-09-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause:the surgeon revised liner height, which is a common practice to restore the joint stability.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 4L - 10MM
• 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: 25528754
• Report Number: 3005180920-2026-00589
• Device Sequence Number: 9744146
• Product Code: JWH
• UDI-Device Identifier: 07630971261754
• UDI-Public: 07630971261754
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/17/2026

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 Model Number: 02.12.E0410FL
• Device Lot Number: 2523345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White