MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422255

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 10/01/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to the loosening of the tibial component.All parts were removed.No more information is available.

Manufacturer Narrative

It was reported that revision surgery was performed due to the loosening of the tibial component.All parts were removed.The associated journey uni oxinium femoral component, journey uni tibial baseplate and journey uni insert, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.The review of manufacturing records was conducted and it did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes could include but are not limited to traumatic injury, bone degeneration 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, 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.

• Brand Name: JOURNEY UNI TIBINRT S3-4RM/LL8MM
• 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: 9251632
• MDR Text Key: 164157291
• Report Number: 1020279-2019-03773
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582164
• UDI-Public: 03596010582164
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71422255
• Device Catalogue Number: 71422255
• Device Lot Number: 16HM597
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1