MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17 MM

Model Number	02.12.0317FR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Tibial insert flex (standard pe) could not be clipped into the tibial tray.As no back-up was available (only 14 and 20 mm was available), the surgeon used a clean blade to slightly trim off material from the insert where impingement was perceived and was able to place the insert.
Additional Manufacturer Narrative
Batch review performed on 3 october 2025 gmk-sphere 02.12.0317fr gmk-sphere tibial insert - flex s3r - 17 mm (k121416) lot 2435952: (b)(4) items manufactured and released on 04-mar-2025.Expiration date: 16-feb-2030.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-sphere 02.07.1203r tibial tray fix cemented s.3r (k090988) lot 2501955: (b)(4) items manufactured and released on 13-jun-2025.Expiration date: 13-may-2030.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.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 surgical blade in the areas where impingement was perceived.After this modification, the insert was finally able to clip onto the tray.The available x-ray images do not provide additional useful information for the investigation, as the polyethylene insert is radiolucent.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 unclipping 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.R&d analysis based on the info provided during a total knee arthroplasty procedure, the tibial insert could not be properly engaged with the tibial tray.The root cause of the unclipping event cannot be conclusively determined based on the information available.The presence of small particles or interposed material between the tibial tray and the insert at the time of assembly could have prevented proper engagement and contributed to the reported difficulty.The surgeon decided to modify the insert by trimming it with a surgical blade in the areas where impingement was perceived.Consequently, any such modification may adversely affect the device's performance and cannot be considered within the intended use of the product.Potential repercussions of this deviation include insert instability, improper engagement, or the generation of residual polyethylene particles resulting from the trimming process.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17 MM
• 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: 23425360
• Report Number: 3005180920-2025-01056
• Device Sequence Number: 9864023
• Product Code: JWH
• UDI-Device Identifier: 07630030826467
• UDI-Public: 07630030826467
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 02.12.0317FR
• Device Lot Number: 2435952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American