JOURNEY 74022116Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6 · Class 2 · Implant
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Journey II femoral component is part of a cemented artificial knee. The 26 reports describe pain, swelling, limited movement, infection and instability, often mentioning revision surgery or other follow-up procedures. All 26 reports mention injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00885556169964), received between Apr 24, 2017 and Jul 3, 2025 — classified as 26 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 reports).
4 other recalls cover devices cleared under the same FDA submission (K111711, K230653); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information18
- Adverse Event Without Identified Device or Use Problem7
- Physical Resistance/Sticking1
Patient problems
- Pain8
- Injury7
- Loss of Range of Motion2
- Post Operative Wound Infection2
- Pulmonary Embolism2
- Unspecified Infection2
- Damage to Ligament(s)1
- Erythema1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT INVOLVING THE (1) JRNY II BCS FEMORAL OXIN RT SZ 6. THIS ADVERSE EVENT WILL NEED A REVISION SURGERY TO BE TREATED (EXACT DATE NOT DEFINED). CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.
Patient problems: Damage to Ligament(s); Insufficient Information
MAUDE report 22391824 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT TKA PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED AN INFECTED KNEE JOINT APPROXIMATELY 3-4 WEEKS POST OPERATIVELY; SO A 2-STAGE REVISION SURGERY HAD TO BE PROGRAMMED. THE FIRST STAGE WAS PERFORMED ON (B)(6) 2023, WHERE THE PRIMARY JRNY II IMPLANTS (JRNY II BCS FEMORAL OXIN RT SZ 6, JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM, JOURNEY TIBIA BASE NP RT SZ 6, GII OVAL RESURFACING PAT 35MM) HAD TO BE REMOVED, AND AN ARTICULATING CEMENT SPACER WITH ANTIBIOTIC WAS IMPLANTED. SECOND STAGE REVISION SURGERY WAS PLANNED WITH IN A PERIOD OF 12 WEEKS, PROVIDING INFECTION SETTLED DOWN.
Patient problems: Unspecified Infection
MAUDE report 16690311 ↗InjuryOct 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED INSTABILITY. A SECOND REVISION SURGERY WAS PERFORMED TO EXCHANGE THE JOURNEY II SIZE 6 RIGHT BCS FEMORAL COMPONENT. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 10624666 ↗InjuryJan 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN, ANASTOMOTIC LEAKAGE AND FEELING OF ILLNESS.
Patient problems: Injury; Pain
MAUDE report 9652748 ↗InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED AN ASPIRATION PERFORMED DUE TO CONTINUED PAIN AND SWELLING AT THE RIGHT KNEE.
Patient problems: Pain
MAUDE report 9349478 ↗InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD AN ARTHROSCOPY PERFORMED DUE TO PERSISTENT PAIN.
Patient problems: Pain
MAUDE report 8624632 ↗InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED BILATERAL PULMONARY EMBOLISM AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH HOSPITALIZATION AND MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAD TO RECEIVE REMEDIAL THERAPY TO RESOLVE THE ADVERSE EVENT.
Patient problems: Pulmonary Embolism
MAUDE report 8600431 ↗InjuryMay 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LIMITED RANGE OF MOTION AFTER RIGHT TOTAL KNEE ARTHROPLASTY FOR WHICH MANIPULATION UNDER ANESTHESIA WAS PERFORMED.
Patient problems: Injury
MAUDE report 8582880 ↗InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
(B)(6) STUDY; SUBJECT: (B)(6); AE#03: ARTHROFIBROSIS RIGHT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED FOR WHICH SUBJECT WAS HOSPITALISED.
Patient problems: Injury
MAUDE report 8536244 ↗InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.
Patient problems: Injury
MAUDE report 8347921 ↗InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.
Patient problems: Pain
MAUDE report 8347882 ↗InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A KNEE ASPIRATION DUE TO PERSISTENT PAIN AND KNEE IS TURNING BLACK.
Patient problems: Pain
MAUDE report 8347858 ↗InjuryJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED AN IT BAND SYNDROME AND RIGHT PATELLA FEMORAL CLUNK CREPITATION FOR WHICH A KNEE ARTHROSCOPY WAS PERFORMED. NO REVISION REQUIRED. NO ADDITIONAL INFORMATION SPECIFIED.
Patient problems: Injury
MAUDE report 8260677 ↗InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT IN 2017, PATIENT HAS PERSISTENT PAIN AND KNEE IS TURNING BLACK. PATIENT RECEIVED AN INJECTION TO TREAT THE PAIN.
Patient problems: Foreign Body Reaction; Implant Pain; Inadequate Osseointegration; Inadequate Pain Relief; Loss of Range of Motion; Pain
MAUDE report 8223546 ↗InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANTATION THERE WAS A SURGERY COMPLICATION, PATIENT HAD A PULMONARY EMBOLISM/ DVT.
Patient problems: Pulmonary Embolism; Thrombosis
MAUDE report 8051051 ↗InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT SUFFERED FROM DERMATITIS SINCE TWO WEEKS AFTER THE KNEE REPLACEMENT ON BOTH LEGS. PATIENT IS WILLING TO OBTAIN A METAL ALLERGY TEST (MELISA TESTING) FROM A MEDICAL INSTITUTE IN (B)(6). PATIENT HAS RECEIVED MULTIPLE DUPIXENT INJECTIONS, ONCE EVERY TWO WEEKS SINCE (B)(6) 2017 FOR RASH AND ITCHING.
Patient problems: Skin Irritation
MAUDE report 7519298 ↗InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED FOR RIGHT KNEE ARTHROSCOPIC SYNOVECTOMY AND HYPERTROPHIC SCAR REMOVAL.
Patient problems: Injury
MAUDE report 7337825 ↗InjuryNov 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THE RIGHT KNEE FOR PATELLAR COMPONENT AND POLY EXCHANGE DUE TO KNEE PAIN, LEG PAIN, ASSOCIATED SWELLING AND LOOSENING OF INTERNAL PROSTHESIS RIGHT KNEE.
Patient problems: Joint Swelling
MAUDE report 7035676 ↗InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST TKA PATIENT HAD PAINFUL RIGHT KNEE RESTRICTED RANGE OF MOTION WHICH WAS RESOLVED BY MEANS OF MANIPULATION UNDER ANESTHESIA.
Patient problems: Loss of Range of Motion
MAUDE report 7023917 ↗InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT PRESENTED WITH RIGHT KNEE POST-OPERATIVE INFECTION. AN UNKNOWN SURGICAL PROCEDURE WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 6833415 ↗InjuryAug 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO PAINFUL RIGHT KNEE, RECURRENT EFFUSION (NO INFECTION) AND CHRONIC INSTABILITY.
Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain
MAUDE report 6829613 ↗InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT PRESENTED WITH A RIGHT KNEE WOUND. THE PATIENT UNDERWENT A DEBRIDEMENT OF SKIN AND TENDON.
Patient problems: Post Operative Wound Infection
MAUDE report 6822162 ↗InjuryAug 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS REQUIRED DUE TO INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 6769439 ↗InjuryJul 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE SUBJECT EXPERIENCED BILATERAL KNEE PAIN. IT WAS UNSPECIFIED WHICH CONSERVATIVE METHOD WAS USED TO RESOLVE ISSUE.
Patient problems: Pain
MAUDE report 6690263 ↗InjuryMay 1, 2017Insufficient Device Problem Information
IT WAS REPORTED THROUGH CLINICAL STUDY THAT THE SUBJECT RECEIVED MEDICATION IN ORDER TO ADDRESS RIGHT KNEE REDNESS. SEVERITY WAS DEEMED MODERATE, EVENT END DATE WAS REPORTED (B)(6) 2012 WITH OUTCOME RESOLVED AND REMEDIAL THERAPY GIVEN WAS REPORTED TO BE: LEVAQUIN 50MG DAILY X7 DAYS AND KEFLEX 500MG Q6 HR. (B)(6) ONWARDS.
Patient problems: Erythema
MAUDE report 6533703 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.
- Z-0158-2024 · Sep 27, 2023 · Open, ClassifiedJOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
- Z-0157-2024 · Sep 27, 2023 · Open, ClassifiedJOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
- Z-2621-2023 · Aug 31, 2023 · Open, Classifiedsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
- Z-1099-2022 · Apr 19, 2022 · TerminatedLEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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