MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE CUTTING BLOCK KIT TCFB; TEMPLATE

Catalog Number V0100042

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 02/26/2019

Event Type  Injury  

Event Description

It was reported that after surgery, when checking the x-rays, it was noticed that there was a femoral and a tibial varus misalignment, which result in an oblique joint line.

Manufacturer Narrative

Results of investigation: it was reported that after surgery, when checking the x-rays, it was noticed that there was a femoral vagus misalignment.The associated visionaire cutting guide kit was returned and evaluated.Visual inspection of the returned product found no obvious signs of damage.Our investigation including an engineering analysis by our visionaire team noted that after evaluation, it was determined that the proximal and distal alignment points were incorrectly placed on the mri.This resulted in the femur being misaligned.A clinical evaluation noted that the x-rays provided appear to show correct alignment of the tibial and femoral component and then it could be a shift to a varus alignment of the knee over the next week but with the limited post-operative images provided, this cannot be confirmed as mechanical axis cannot be measured in the postoperative images to confirm if there was migration over time or due to incorrect implantation axis.The provided operative report does not indicate a reason for a shift of the components.It is noted that palacos cement was used for fixation which is not smith and nephew product and if there was a post operative migration of the components this would not be a result of the visionaire plan or patient specific instruments.Dhr review yields that all appropriate manufacturing and inspection steps took place.No root cause for the described complaint can be determined by the dhr review.No other similar complaint has been identified in the review of the last three years (2016, 2017, 2018).The impact to the patient beyond the oblique joint line cannot be concluded.

• Brand Name: VISIONAIRE CUTTING BLOCK KIT TCFB
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8582189
• MDR Text Key: 144134144
• Report Number: 1020279-2019-01755
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2019
• Device Catalogue Number: V0100042
• Device Lot Number: 00132270V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART: V0100042, LOT: 00132270V2 VISIONAIRE KIT TC.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80