MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4RM/LL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71422256

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/20/2017

Event Type  Injury  

Event Description

It was reported a slow post-op recovery due to pain.

Manufacturer Narrative

It was reported a slow post-op recovery due to pain.The affected juni femoral components, juni tibial baseplates and juni inserts, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch 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 could not be corroborated.A clinical analysis noted that the cause of pain during the immediate post- operative period of a bilateral knee is normal and is expected during the post- operative healing and rehab phase.Since no other interventions were required and the issue was reported as resolved, no further clinical/medical assessment is warranted at this time.Review of the ifu and risk management files identified the reported failure as potential adverse events.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: JOURNEY UNI TIBINRT S3-4RM/LL9MM
• 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: 8176806
• MDR Text Key: 130763941
• Report Number: 1020279-2018-02834
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582171
• UDI-Public: 03596010582171
• 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: 06/08/2020

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: 03/28/2024
• Device Model Number: 71422256
• Device Catalogue Number: 71422256
• Device Lot Number: 14CM21859
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization