MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW JOURNEY II; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2016

Event Type  Injury  

Event Description

Total knee replacement from (b)(6) 2016 came loose using palacos cement & smith & nephew journey ii from tibia and had to be revised on (b)(6) 2021.I also know that there have been many others that have had the same issues used from same orthopedic facility.Fda safety report id# (b)(4).

• Brand Name: SMITH & NEPHEW JOURNEY II
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 12143228
• MDR Text Key: 261076130
• Report Number: MW5102421
• Device Sequence Number: 2
• Product Code: HRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 81