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

Model Number V0100112

Device Problem Fitting Problem (2183)

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

Event Date 06/10/2021

Event Type  Injury  

Event Description

It was reported that during tka surgery the doctor pinned the visionaire femoral guide into place and made his distal femoral cut.When he put the size 4 planned size cutting guide into the pre drilled holes it seemed to have put them into extreme external rotation and would have taken off and estimated 15+ mm of bone off the posterior medial side.He then decided to change to conventional instrumentation and sized the femoral to a size 5 and the rotation was put correctly to 3 degrees of external rotation.They then used the visionaire tibial cutting guide and seemed to line up correctly and made the resection.When they checked the pre drilled tibial rotation, it again was extremely externally rotated.We then corrected that inter-op and sized it up one size from a 2 to a 3.Patient was not harmed as consequence of this problem.It is unknown if there was a surgical delay.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the reported event could be confirmed according to the engineering evaluation.The clinical/medical investigation concluded that, per complaint details, the visionaire¿ guides resulted in ¿extreme external rotation¿; therefore, the surgeon changed to convention instrumentation and ¿corrected that inter-op and sized up one size¿ on the femur and tibia.Reportedly, the surgery was performed with a change in the surgical technique without patient injury within a 0-30 minutes surgical extension.Further clinical documentation has not been provided as of the date of this medical assessment.The engineering evaluation confirmed an ¿over-segmentation of the posterior femur¿ and ¿downsizing the femur¿ as potential root causes for the stated failure mode.The visionaire¿ surgical technique does recommend use of back-up instrumentation should the adaptive guide be determined unsuitable for its intended use.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure within a 0-30 minute surgical extension with a change of surgical technique and ¿corrected that inter-op¿ with no patient injury alleged.Based on this information, no further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 with inspection drawing, part number, size, implant type, hand, recut type, saw blade thickness and part configuration should be verified, besides dimensions should be measured with caliper to ensure print specifications.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that the oversegmentation of the posterior femur would have affected the rotation of the femur.It was also determined that tibia implant was internally rotated instead of being externally rotated as stated in the complaint.It was also determined that the femur was downsized to match compatibility with the tibia size when the engineer should have upsized the tibia for compatibility with the femur.Based on this investigation, the need for corrective action is not indicated as the failure mode rate is within the anticipated acceptable risk limit in the risk management plan.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Possible causes could include a defect during manufacturing processes, including segmentation error and downsizing the dimension of the device.The contribution of the device to the reported event could be corroborated due to errors during manufacturing process, generating an extreme external rotation and a delay during surgery.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 KIT JII
• 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: 12086529
• MDR Text Key: 258980657
• Report Number: 1020279-2021-05537
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00202490V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• 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