JOURNEY 74024832Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY BCS PATELLA RESURFACING ROUND 32 MM STANDARD · 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 BCS knee implant replaces the kneecap surface during total knee replacement surgery. The 29 adverse event reports mostly describe ongoing knee pain, stiffness, and scarring after surgery, with several patients needing repeat operations under anesthesia to free a stiff joint, and one report of the implant dislocating. All 29 reports describe 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010554536), received between Oct 10, 2017 and Oct 20, 2021 — classified as 29 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 reports).
4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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.
Most reported problems
Device problems
- Insufficient Device Problem Information21
- Adverse Event Without Identified Device or Use Problem7
- Device Dislodged or Dislocated1
Patient problems
- Injury18
- Fibrosis2
- Inflammation2
- Unspecified Infection2
- Discomfort1
- Fall1
- Hypersensitivity/Allergic reaction1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT HAS HAD UNSPECIFIED SYMPTOMS ASSOCIATED TO COBALT ALLERGY. THE PATIENT ALSO REPORTS THAT 2 MANIPULATION SURGERIES, 6 MONTHS OF PT, AND PAIN BLOCKERS PUT IN POST SURGERY MADE HER LOSE QUAD MUSCLE FOR ALMOST A YEAR. A REVISION SURGERY MIGHT BE REQUIRED TO SOLVE THE REPORTED EVENT; BOTH THE FEMUR AND THE PATELLA CONTAIN TRACE AMOUNTS OF COBALT; THEREFORE, IT IS UNCERTAIN WHICH COMPONENT, IF ANY OR BOTH, IS CAUSING THE REACTION. THE CONDITION OF THE PATIENT IS ONGOING.
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Implant Pain; Muscle Weakness/Atrophy
MAUDE report 12665977 ↗InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED BY IMPLANTING A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED DEEP SCAR FORMATION DUE TO A FALL. THE EVENT WAS TREATED VIA PROCEDURE: SYNOVECTOMY. THE SITUATION IS CONSIDERED RESOLVED.
Patient problems: Fall; Injury; Scar Tissue; Swelling/ Edema
MAUDE report 10082467 ↗InjuryMar 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6), DUE TO DISLOCATION. THE REVISION WAS PERFORMED AND ONLY THE POLY WAS SWAPPED WITH A NEW IMPLANT. THE PATIENT IS CURRENTLY UNDER RECOVERY, THE SURGEON DIDN'T ADVISE MEDICATION.
Patient problems: Injury
MAUDE report 9801361 ↗InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 8868024 ↗InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 8868013 ↗InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO ARTHROFIBROSIS ON THE LEFT KNEE.
Patient problems: Injury
MAUDE report 8867901 ↗InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 8867687 ↗InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE PAIN AND STIFFNESS AND IT WAS RESOLVED WITH A MANIPULATION UNDER ANESTHESIA.
Patient problems: Injury
MAUDE report 8845186 ↗InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE ARTHROFIBROSIS.
Patient problems: Fibrosis
MAUDE report 8834734 ↗InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WHICH WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.
Patient problems: Fibrosis
MAUDE report 8834729 ↗InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT SUFFERED A FALL. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED DUE TO LEFT KNEE ARTHROFIBROSIS. EVENT WAS RESOLVED.
Patient problems: Injury
MAUDE report 8739741 ↗InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE.
Patient problems: Injury
MAUDE report 8727655 ↗InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.
Patient problems: Injury
MAUDE report 8704616 ↗InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED LEFT LOWER EXTREMITY NEURITIS. ADVERSE EVENT TREATED WITH MEDICATION. OUTCOME OF THE EVENT IS UNKNOWN.
Patient problems: Injury
MAUDE report 8704611 ↗InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL. CIRCUMSTANCES ARE NOT SPECIFIED. EVENT WAS RESOLVED WITH MEDICATION AND CONSERVATIVE APPROACH.
Patient problems: Injury
MAUDE report 8704603 ↗InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A MANIPULATION UNDER ANESTHESIA DUE TO THE KNEE IS BARELY AT 60° OF FLEXION AND THE PATIENT CERTAINLY LACKS THE LAST 15 OR SO DEGREES OF EXTENSION. INTENSIFYING PHYSIOTHERAPY AND REHABILITATION IS FAILING TO MAKE ANY SIGNIFICANT OR MEANINGFUL PROGRESS.
Patient problems: Injury
MAUDE report 8661089 ↗InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN IN THE LEFT KNEE, WHICH WAS TREATED CONSERVATIVELY.
Patient problems: Pain
MAUDE report 8660941 ↗InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAS DEEP VEIN THROMBOSIS ON THE RIGHT KNEE. THE ISSUE HAS BEEN RESOLVED WITH MEDICATION THERAPY.
Patient problems: Swelling
MAUDE report 8461850 ↗InjuryJan 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED A LEFT KNEE ACL/BRIDGE LOOSENING. EVENT TREATED WITH CANNULATED SCREW FIXATION. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Injury
MAUDE report 8289502 ↗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 8051050 ↗InjuryOct 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO KNEE INSTABILITY.
Patient problems: Injury
MAUDE report 8022080 ↗InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 7899650 ↗InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A SURGICAL PROCEDURE IS SCHEDULED FOR EXAMINATION UNDER ANESTHESIC, ARTHROSCOPY AND ARTHROSCOPIC ARTHROLYSIS.
Patient problems: No Information
MAUDE report 7561348 ↗InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN ASPIRATION OF THE RIGHT KNEE WAS PERFORMED DUE TO INFECTION AND INFLAMMATION REACTION.
Patient problems: Unspecified Infection
MAUDE report 7206136 ↗InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ACUTE PERIOPROSTHETIC JOINT INFECTION AND PATELLAR TENDINITIS.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 7157420 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042515, K091014, K230653. One submission often covers many models, so check the product and lot details in each record.
- 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-0001-2019 · Jun 13, 2018 · Open, ClassifiedJourney BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
- Z-0003-2019 · Jun 13, 2018 · Open, ClassifiedJOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
- Z-0002-2019 · Jun 13, 2018 · Open, ClassifiedJOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112
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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