MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS UNI LM/RL XS TIB BASE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 726100

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/17/2018

Event Type  Injury  

Event Description

It was reported that genesis system was implanted in (b)(6) 2018 and the femoral component was explanted in (b)(6) 2019 due to pain and mobilization.No more information available.

Manufacturer Narrative

It was reported that genesis system was implanted in (b)(6) 2018 and the femoral component was explanted in (b)(6) 2019 due to pain and mobilization.The affected devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Smith and nephew has been unable to obtain device details.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Possible causes could include but not limited to alignment or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

Manufacturer Narrative

Updated results of investigation: it was reported that genesis system was implanted in (b)(6) 2018 and the femoral component was explanted in (b)(6) 2019 due to pain and mobilization.The affected genesis uni tibial base, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Smith and nephew has been unable to obtain device details.As device information was not made available, device history record review cannot be completed.A complaint history for the tibial base revealed no prior complaints for the listed failure mode.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Possible causes could include but not limited to alignment or size of device.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS UNI LM/RL XS TIB BASE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9256146
• MDR Text Key: 164297651
• Report Number: 1020279-2019-03828
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 726100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR