MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBIAL BASE RM/LL SZ 6; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71422436

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/21/2020

Event Type  Injury  

Event Description

It was reported that a revision of journey uni was performed as the insert had disassociated from the tibial component for a second time.The insert had already been revised at an earlier stage.

• Brand Name: JOURNEY UNI TIBIAL BASE RM/LL SZ 6
• 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: 9641869
• MDR Text Key: 176784663
• Report Number: 1020279-2020-00411
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K102069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/17/2023
• Device Catalogue Number: 71422436
• Device Lot Number: 13LM13867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Treatment: 71422436 JRNY UNI TIBIAL BASE, 13LM13867.
• Patient Outcome(s): Required Intervention