MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS ADPT GUIDE LGNP KIT; PRSTHESIS, KNEE,SMI-CONSTRAINED, CMNTD, POLYMER/MTL/POLYMR

Model Number V0200109

Device Problem Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Date 12/10/2019

Event Type  Injury  

Event Description

It was reported that an additional 2mm bone hole was necessary due to the distal alignment was approximately 12 degrees rather than 5 degrees.Also for tibia the visionaire cutting block was placed on the patient using the alignment rod and fixated using pins.It appeared to the surgeon to not be in the correct alignment.He opted to use the traditional legion primary tibial instrumentation.

Manufacturer Narrative

Results of investigation: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical analysis indicated that no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of the manufacturing records yields that all appropriate manufacturing and inspection steps took place.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No root cause for complaint description can be determined by dhr review.After evaluation, it was determined that under segmentation of a tibial osteophyte caused the incorrect tibia alignment in the complaint.No cause was found for the incorrect femur alignment in the complaint.A review of the risk management file and instructions of use for the product was completed.The devices are single use instruments; possible causes could include but not limited to design error, feature changes/ errors, or functional failures.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Type of Device: PRSTHESIS, KNEE,SMI-CONSTRAINED, CMNTD, POLYMER/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9553267
• MDR Text Key: 173772848
• Report Number: 1020279-2020-00110
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (y/n): N
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/27/2020

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: 07/05/2020
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00161885V1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 09/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention