MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422265

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/08/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to implant malfunction.Insert and tibial tray explanted.Back up available.

Manufacturer Narrative

The affected journey uni tibial insert and journey uni tibial baseplate were not returned for evaluation.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that no clinical relevant documents were provided to conduct a thorough medical assessment, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/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: 8030427
• MDR Text Key: 125861883
• Report Number: 1020279-2018-02337
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582249
• UDI-Public: 03596010582249
• 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: 03/19/2019

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 Catalogue Number: 71422265
• Device Lot Number: 17KM16879
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention