MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 MM

Model Number	02.12.0310FL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was not possible to couple the pe insert with the tinbn coated tibial tray.Back-up insert used, but the same problem occurred.Eventually, the surgeon was able to seat the liner.Delay 20-30 min (90 minutes total surgery).
Additional Manufacturer Narrative
Batch review performed on 06 jun 2025 (b)(4) items manufactured and released on 10-12-2024.Expiration date: 2029-11-25.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 devices involved: gmk-sphere 02.07.2803l fixed tibial tray size 3 l - tinbn coating (k202684) lot.2340801 batch review performed on 06 jun 2025.(b)(4) items manufactured and released on 30-12-2024.Expiration date: 2029-12-09.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 02.12.0310fl gmk-sphere tibial insert - flex s3l - 10 mm (k121416) lot.2432422 batch review performed on 06 jun 2025.(b)(4) items manufactured and released on 15-02-2024.Expiration date: 2029-01-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager this visual inspection is based on the analysis of the component object of the reported event sent back to medacta headquarters.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.Although no root cause can be confirmed for this case, it is most likely that in the first attempts to fix the insert into the baseplate, the insert was not well positioned and became damaged, precluding the possibility to fix the insert in the following attempts.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.Device evaluation: d9, h3.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S3L - 10 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: 22380966
• Report Number: 3005180920-2025-00614
• Device Sequence Number: 13120805
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• 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): 09/24/2025

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: 02.12.0310FL
• Device Lot Number: 2431658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White