MAUDE Adverse Event Report: Medacta International SA Knee Instruments; Sphere Insert Instrument Set I2R-T2

Model Number	11.01032
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The trial insert 10mm did not engage the trial tibial baseplate since the anterior clipping part of the trial insert was broken.The cause and the timing of the breakage was unknown.The surgery was completed successfully, but the insert thickness was selected without an adequate trial reduction.The surgery time was 3 hours, and the delay time was 30 minutes.
Additional Manufacturer Narrative
Batch review performed on 29 jul 2026 lot 2613339: (b)(4) items manufactured and released on 11-jun-2026.Expiration date: 25-may-2031.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.Considering the semifinished lot (mat88198) of the device involved in this complaint, (b)(4) items were manufactured and released 19-mar-2026.To date, no similar events have been reported on the same semifinished lot during the period of review.Considering the semifinished lot (mat88594) of the device involved in this complaint, (b)(4) items were manufactured and released 13-mar-2026.To date, no similar events have been reported on the same semifinished lot during the period of review.R&d analysis the visual analysis confirms the difficulty of clipping the efficiency trial inserts into the trial baseplate.The reason for this complaint could be that, during the initial insertion, the baseplate connection features became slightly deformed or damaged, making clipping more difficult.To improve the baseplate-trial insert connection system, the baseplate design has been updated to ensure insert stability through the addition of lateral retaining walls, as is currently implemented in the metal instrumentation.Root cause: based on the available information, no definitive root cause can be established, while the investigation does not indicate a potential manufacturing-related issue or systemic deficiency.

• Brand Name: Knee Instruments
• Common Device Name: Sphere Insert Instrument Set I2R-T2
• 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: 50474948
• Report Number: 3005180920-2026-00831
• Device Sequence Number: 10112372
• Product Code: LXH
• UDI-Device Identifier: 07630030878602
• UDI-Public: 07630030878602
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 11.01032
• Device Lot Number: 2613339
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: Asian