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

Model Number	02.12.E0410FR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 march 2026.Gmk-spherika 02.12.E0410fr gmk-sphere tibial insert e-cross - flex 4r - 10mm (k202022), lot: 2526543: (b)(4) items manufactured and released on 24-oct-2025.Expiration date: 2030-10-09.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 02.12.3d04r gmk 3dmetal tibial tray size 4r cementless (k221850), lot: 2407418: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 2029-04-25.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.Clinical evaluation: during a total knee arthroplasty, the tibial insert could not be properly clipped into the tibial tray.The surgeon therefore decided to trim the insert using a scalpel in the areas where impingement was perceived.After this modification, the insert was finally able to clip onto the tray.It should be noted that medacta polyethylene inserts are not intended to be modified or trimmed, as done in this case.Therefore, potential repercussions cannot be excluded, such as insert instability or the presence of residual polyethylene particles resulting from the trimming process.The root cause of the event is difficult to determine.The surgical technique clearly describes the steps required to ensure proper clipping, emphasizing that the tibial baseplate must be perfectly clean and free of any debris.The presence of small particles or interposed material between the tray and the insert during assembly could hinder proper engagement and lead to difficulties in achieving fixation.Root cause:although it cannot be confirmed, the issue may have resulted from unique conditions of the specific surgical application, particularly involving the insert not being well aligned during the first clipping attempt, resulting in damage which prevented subsequent attempts.The device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
During the primary right knee surgery, the surgeon was having difficulty getting the insert to fit into the tibial tray.The surgeon attempted the force of push and hitting the insert onto the tray, but it would not successfully seat.The surgeon used a scalpel and trimmed the posterior lateral edge of the insert and was then able to push it onto the tibial tray.The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4R - 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: 24882488
• Report Number: 3005180920-2026-00295
• Device Sequence Number: 21306531
• Product Code: JWH
• UDI-Device Identifier: 07630971261761
• UDI-Public: 07630971261761
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.12.E0410FR
• Device Lot Number: 2526543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2025
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male