MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN UKR SYSTEM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 01/13/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a navio unicompartmental procedure on (b)(6) 2020 and continued to loose feeling and had pain in their surgical leg.The nerve conduction studies showed loss of the great saphenous nerve and currently they continue to lose nerve function in the leg.

Manufacturer Narrative

The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.As device information was not made available, device history record , risk management review and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.According to clinical/medical investigation team, per complaint details, a patient had onset of pain and loss of nerve function following a navio uni knee arthroscopy.S+n has not received the requested documentation to fully evaluate the root cause of the reported event.However, the ifu [81087148 rev a] knee systems does note that peripheral neuropathies have been reported following total joint surgery.The patient impact beyond the reported pain and loss of nerve function could not be determined.Should clinically relevant documentation/information become available, the clinical/medical task may be re-opened for further evaluation.No further medical assessment is warranted at this time.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore, no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKNOWN UKR SYSTEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10624783
• MDR Text Key: 209744024
• Report Number: 1020279-2020-05157
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability