MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

Model Number	02.12.0210FL
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Failure of coupling of the 10 mm and 11 mm inserts with the tibial tray.A 12[?]mm insert was finally implanted.Surgery was prolonged by about 50 minutes.The surgery concluded successfully.
Additional Manufacturer Narrative
Batch review performed on 09 july 2025 gmk-sphere 02.12.0210fl gmk-sphere tibial insert - flex s2l - 10 mm (k121416) lot.2429204: (b)(4) items manufactured and released on 3-dec-2024.Expiration date: 2029-nov-14.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.Additional components involved in the event: batch review performed on 09 july 2025 gmk-sphere 02.07.1202l tibial tray fix cemented s.2l (k090988) lot.2436402: (b)(4) items manufactured and released on 24-march-2025.Expiration date: 09-march-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.Gmk-sphere 02.12.0211fl gmk-sphere tibial insert - flex s2l - 11 mm (k140826) lot.2427644: (b)(4) items manufactured and released on 31-oct-2024.Expiration date: 14-oct-2029.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.Visual inspection an intra-operative issue was reported involving the coupling mechanism between the tibial baseplate and insert of a gmk sphere implant.A visual inspection was conducted on the retrieved 10 mm and 11 mm tibial inserts associated with the event.Both inserts exhibited damage localized primarily in the lateral posterior engagement zones-areas designed to interface with the corresponding regions of the tibial baseplate.The damage was characterized by incision-like markings consistent with the peripheral geometry of the baseplate, suggesting impingement during the coupling process.It is believed that during initial insertion attempts, the insert may have been misaligned with the baseplate.This misalignment likely led to localized damage, which in turn prevented secure fixation in subsequent attempts.A third insert (12 mm) was opened and successfully coupled with the baseplate, resolving the issue.Based on visual assessment, there is no indication of a manufacturing defect or device malfunction.The issue appears to be related to intra-operative technique rather than product performance.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 potential manufacturing related issue.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L
• 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: 22573888
• Report Number: 3005180920-2025-00691
• Device Sequence Number: 9474094
• Product Code: JWH
• UDI-Device Identifier: 07630030826139
• UDI-Public: 07630030826139
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121416
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: 02.12.0210FL
• Device Lot Number: 2429204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian