MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS ADPT GUIDE LGNP KIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	V0200109
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that before a tkr procedure, when looking at the plan for visionaire, using one (1) ns vis adpt guide lgnp kit, the plan indicated genesis 2 as the implant when it was meant to be legion.After discussion with the engineers it was agreed that the plan was for a legion but had been incorrectly named as a genesis 2.During the tkr, while inspecting the femur visionaire block on the native femur, it appeared to sit up approximately 2 mm on the medial side.Proceeding with the surgery, using the visionaire block, the posterior gaps of the medial side cuts were measured, and it was noticed that it were over resected by 4mm from the plan.The procedure was resumed, after a non-significant delay, with a change in surgical technique, from cruciate retaining to posterior stabilized for better stabilization.This change required more surgical steps and additional cutting of the femur to accommodate a ps box.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed the femur segmentation did not meet established standards, as the anterior medial face was under-segmented, resulting in an incorrect block fit.This device is patient-specific and custom-made for an individual case, so the dimensional issue is isolated to this single-use product.No additional containment actions are required.The responsible engineer has been informed of the error.The clinical/medical investigation concluded that, the root cause was identified as human error, including mislabeling of the pre-operative plan and segmentation inaccuracies that affected guide fit.The excessive bone removal and subsequent change in surgical technique could have been avoided by using backup instruments when the fit issue was observed.A variation in surgical technique contributed to the switch to a different implant system, which required additional steps and removal of the posterior cruciate ligament.A review of complaint history of the previous 12 months revealed similar events for the listed part number, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for visionaire¿ patient matched instrumentation revealed that if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.Also, according to the label specification and packaging sequence, labels should include the information (side) according to the device placed in the package.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to inspection drawings, part number, size, implant type, hand, recut type and sawblade thickness shall be verified.Also, part configuration shall be compared to print.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23700165
• Report Number: 1020279-2025-01990
• Device Sequence Number: 13326619
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 885556656563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2026
• Device Catalogue Number: V0200109
• Device Lot Number: 00311159V3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male