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

Model Number V0100109

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tka surgery, where visionaire adaptive guide kit legion primary were used, the femoral block cut patient in too much extension and the tibial block cut patient in too much varus.Surgeon had to recut twice on femur and tibia to adjust his square extension/flexion gaps.It is unknown if this caused any delay to the procedure, as well as the outcome of the patient.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the requested medical documentation has not been provided as of the date of this medical investigation.The current health status of patient remains unknown.The patient impact beyond the reported unanticipated exaggerated cuts which resulted in the need for re-cuts/modified surgical procedure could not be determined.No further medical assessment could be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.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.A review made by the quality engineering team revealed that errors were made in the segmentation of the tibia which could have affected the block fit and alignment of just the tibia.There was no root cause identified for the complaint of the femur resection.The responsible segmentor has been made aware of the segmentation error for the case.At this time we do have reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used, user/procedural variance or segmentation error.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.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.A review made by the quality engineering team revealed that errors were made in the segmentation of the tibia which could have affected the block fit and alignment of just the tibia.There was no root cause identified for the complaint of the femur resection.The responsible segmentor has been made aware of the segmentation error for the case.The clinical/medical investigation concluded that, the requested medical documentation has not been provided as of the date of this medical investigation.The current health status of patient remains unknown.The patient impact beyond the reported unanticipated exaggerated cuts which resulted in the need for re-cuts/modified surgical procedure could not be determined.No further medical assessment could be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.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 the inspection drawing, final inspection includes the verification of part configuration per print.Also the device should be measured with a caliper to ensure the correct size.At this time we do have reason to suspect that the product failed to meet any 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: VIS ADPT GUIDE LGNP KIT
• Type of Device: 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15108034
• MDR Text Key: 296652214
• Report Number: 1020279-2022-03478
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656396
• UDI-Public: 00885556656396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: V0100109
• Device Catalogue Number: V0100109
• Device Lot Number: 00231888V1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female