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

Catalog Number 71422255

Device Problem Mechanical Problem (1384)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 12/29/2014

Event Type  Injury  

Event Description

It was reported that the patient had difficulty reaching full extension/flexion.An intervention of manipulation under anesthesia was performed.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and this is from a retrospective study the adverse event #1 occurred approximately 2 weeks post implantation and was remedied by a manipulation under anesthesia.Several attempts have been made to obtain clinical/medical documents to no available.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 7613815
• MDR Text Key: 111475435
• Report Number: 1020279-2018-01160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Catalogue Number: 71422255
• Device Lot Number: 14CM15101
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR