MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422262

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 03/13/2019

Event Type  Injury  

Event Description

It was reported that the patient presented with infection status post total knee arthroplasty.

Manufacturer Narrative

The associated journey uni tibial baseplate, journey uni tibial insert and journey uni femoral component were not returned for evaluation.Therefore visual inspection could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.Products were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Without the return of the actual product involved nor medical records available, our investigation of this report is inconclusive.Should additional information be received, the complaint will be reopened for investigation.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.

• Brand Name: JOURNEY UNI TIBINRT S5-6LM/RL9MM
• 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: 8489977
• MDR Text Key: 141158117
• Report Number: 1020279-2019-01417
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010582218
• UDI-Public: 03596010582218
• Combination Product (y/n): N
• PMA/PMN Number: K061011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71422262
• Device Lot Number: 17HM13131
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention