MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; GENERAL MIS SPHERE INSTRUMENT SET

Model Number	11.01002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22-dec-2025 lot 2516210: (b)(4) items manufactured and released on 07-jul-2025.Expiration date: 2030-06-23.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.Semifinished lot mat79478: 3300 items manufactured and released on 09-may-2025.No anomalies found related to the problem.To date, no similar event was reported on this lot during the period of review.Clinical evaluation performed by clinical affairs department.The patient underwent tka and the 6 week follow-up x-rays revealed an artifact in the posterior part of the knee joint.Although it cannot be confirmed, and no instrument breakage was reported during primary surgery, it was hypothesized that the artifact could be the tip of the plastic femoral impactor used during primary surgery.While the material of the instrument is not cleared for long-term implantation, it is essentially inert and unlikely to cause problems from a chemical point of view.Considering its location, it is possible for it to damage articular surfaces, in particular the insert, but also the femur, leading to the necessity for an implant replacement.For this reason, arthroscopic removal is deemed necessary and is strongly suggested.On a final note, it should be considered that, without removal of the foreign body it is not possible to confirm it is actually a broken part of the instrument and thus also the material cannot be confirmed.
Event or Problem Description
At 6 weeks post-op x-rays showed an artifact in the posterior part of the femur.Based on the images it is hypothesized to be the tip of the central body of the efficiency impactor/extractor, but this cannot be confirmed.Surgical staff reported that no breakage was noticed during primary surgery.According to the surgeon the patient presents a normal level of pain, compatible with 6 weeks follow-up, and no revision is currently scheduled.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: GENERAL MIS SPHERE INSTRUMENT SET
• 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: 24003049
• Report Number: 3005180920-2026-00016
• Device Sequence Number: 21378447
• Product Code: LXH
• UDI-Device Identifier: 07630030882890
• UDI-Public: 07630030882890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 11.01002
• Device Lot Number: 2516210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown