MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE 02.12.0212FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 12 MM

Model Number	02.12.0212FL
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 09 jul 2025 lot 2423907: (b)(4) items manufactured and released on 03-oct-2024.Expiration date: 2029-09-15.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.Other devices involved: gmk-sphere 02.07.1202l tibial tray fix cemented s.2l (k090988) lot 2432779: (b)(4) items manufactured and released on 14-feb-2025.Expiration date: 2030-01-28.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.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.There is no indication of a systemic deficiency.
Event or Problem Description
After cementing the tibial tray and femoral component to the bone and thoroughly irrigating the site, the surgeon attempted to manually engage the insert multiple times but the attempts were unsuccessful.The surgeon confirmed there were no foreign materials on the tibial tray and cleaned it again.Since manual insertion was not successful, the surgeon used an impactor (ref.02.07.4721), but the insert still did not engage properly.A same size insert (ref.02.12.0212fl, lot 2340847) was implanted, and the surgery completed successfully.The total surgery time was 1.5 hours, and the delay time was 20 minutes.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager intra-operative issue involving the coupling system between the baseplate and uhmwpe tibial insert of a gmk sphere implant.This visual inspection is based on the analysis of the component object of the reported event sent back to medacta headquarter.The insert looks damaged, particularly in the lateral posterior regions intended to engage with the corresponding seating areas of the tibial baseplate.It is believed that during the initial attempts to seat the insert into the baseplate, it may not have been properly aligned or fully engaged.This misalignment likely led to damage of the insert, which subsequently prevented successful fixation in later attempts.Based on the visual assessment, there is no evidence to suggest that the event resulted from a manufacturing defect or device malfunction.The very thin layer of sensitin coating doesn't alter the tolerances of the tibia insert / baseplate coupling system.Device evaluation: d9, h3.Correction: d1.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE 02.12.0212FL GMK-SPHERE TIBIAL INSERT - FLEX S2L - 12 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: 22585411
• Report Number: 3005180920-2025-00694
• Device Sequence Number: 4501821
• Product Code: JWH
• UDI-Device Identifier: 07630030826177
• UDI-Public: 07630030826177
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 02.12.0212FL
• Device Lot Number: 2423907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian