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 Product Quality Problem (1506)

Patient Problem Rupture (2208)

Event Date 10/05/2022

Event Type  Injury  

Event Description

It was reported that, during a visionaire-assisted tka, the surgeon went to use the cutting block and noticed that the holes were not lining up properly.The sales rep noticed that the block was a legion and not journey ii, even though the block and packaging were labeled as such.The issue was recognized after the distal cut was made and the noted size cutting block did not seem to line up correct with the holes from the visionaire block.The sales rep rechecked the surgical plan and noticed the planned implant was for legion and not journey ii.From that point, two additional bone holes were made to fit the journey ii traditional instrumentation to size the femur and moved forward.Traditional instrumentation was used for the tibia.Surgery was not delayed.Patient was not harmed beyond the reported issue.

Manufacturer Narrative

Internal complaint reference: case (b)(4).

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, per complaint details, during a visionaire-assisted total knee arthroplasty the surgeon noted after the distal femoral cut that the cutting block/holes were not lining up properly with those from the visionaire; therefore, two additional bone holes were made to fit the journey ii and traditional instrumentation was used to progress through the procedure.Reportedly, the sales representative noticed that the block was a legion and not journey ii, even though the block and packaging were labeled as such; however, per correspondence, sounds like somehow the wrong implant was selected in the scheduling process.It was communicated that no images or x-rays were available, the patient was not harmed beyond the reported two additional bone holes, and no additional unplanned cuts were made.Based on the information provided, there were no clinical factors found which would have contributed to the event.Although the use of traditional instrumentation is an approved surgical technique, the patient impact beyond the reported additional bone holes, cannot be determined, as it remains unknown if/how this was treated.No further medical assessment can 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.A review made by the quality engineering team revealed that after evaluation, it was found that the root cause of this event was determined to be that the alignment engineer planned the case for a legion primary p/s implant instead of a journey ii bcs implant as it was booked.At this time, we do have reason to suspect 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: 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: 16554410
• MDR Text Key: 311413166
• Report Number: 1020279-2023-00555
• 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: 06/29/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00238395V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• 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