MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA NEXTAR KNEE PLATFORM; MYKNEE NEXTAR TIBPINPOSITIONER_ASS-CT-GMK-RM

Model Number	15,802
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, the distal femoral cut was reported as not straight forward, with an initial under-resection of approximately 3d 4 mm compared to the plan.Additional cuts were subsequently performed; both distal and posterior femoral cuts were ultimately aligned with the preoperative planning and verified with a caliper.The tibial cut was performed as planned.Despite this, post-resection assessment revealed an imbalance in both flexion and extension.When using the planned 10 mm polyethylene spacer, the surgeon observed laxity in both phases, leading to the use of a 13 mm insert to improve stability.However, with the 13 mm trial, the knee became too tight in extension while remaining lax in flexion.A valgus recut with additional bone resection was then performed, although no measurements of the resection depth are available, and this approach appears unusual given the presence of medial instability.The medial compartment was reported to be highly lax, as also indicated by nextar.Due to persistent instability and patient-related factors, a revision tibial component with wedges was implanted.The overall surgical time increased by approximately 50 minutes.Case code: (b)(4).
Additional Manufacturer Narrative
Investigation performed by medacta r&d nextar project manager: the review of the available data suggests that the femoral distal cut in flexion and the tibial posterior slope were not fully aligned with the planned parameters, with a potential impact on resection levels (as observed in the provided videos).The ligament assessment in flexion indicated increased laxity in both medial and lateral compartments, consistent with the intraoperative findings and with the deviation from the preoperative plan.Without the logfile, it is not possible to analyze the nextar navigation data.However, the registration was successfully completed, and the pps fixation ensures that the sensors did not move during surgery.The consistency with caliper measurements suggests that the system was accurate.The reported valgus recut is noted: to achieve medial stability, a varus correction would typically be expected.Moreover, modifying the tibial cut may affect the flexion/extension balance.Additional details on the rationale behind this intraoperative decision would be appreciated.On the medial side of the tibia, there is an osteotomy close to the medial collateral ligament insertion.Although details are limited, this suggests a prior procedure to correct alignment, which may have affected the soft tissue condition and contributed to medial laxity.Overall, this appears to be a complex case in which soft tissue management was particularly challenging.Patient match planning review performed by medacta myknee project manager: the analysis of the process found out no errors: each step of the my solutions process was performed correctly.Root cause:the case was characterized by challenging patient anatomy, including potentially osteoporotic bone quality, which may have affected cutting accuracy.Significant ligamentous laxity may have further contributed to intraoperative instability and influenced the reliability of measurements.In addition, a prior medial tibial osteotomy near the medial collateral ligament insertion may have affected soft tissue condition.Overall, these factors may have contributed to deviations from the planned bone resections.

• Brand Name: NEXTAR KNEE PLATFORM
• Common Device Name: MYKNEE NEXTAR TIBPINPOSITIONER_ASS-CT-GMK-RM
• 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: 24711334
• Report Number: 3005180920-2026-00273
• Device Sequence Number: 14865959
• Product Code: JWH
• UDI-Device Identifier: 07630345731661
• UDI-Public: 07630345731661
• Combination Product (Y/N): N
• PMA/510(K) Number: K213751
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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 Expiration Date: 02/15/2026
• Device Model Number: 15,802
• Device Lot Number: 241756K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2026
• 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: 43 YR
• Patient Sex: Female