JOURNEY 74024835Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY BCS PATELLA RESURFACING ROUND 35 MM STANDARD · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Journey knee implant resurfaces the kneecap during knee replacement. The 42 reports describe stiffness and limited movement, pain and swelling, fractures and kneecap dislocation, often treated with manipulation under anesthesia or revision surgery. There are no deaths and 42 injuries mentioned, and 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
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 03596010554543), received between Aug 30, 2017 and Oct 22, 2020 — classified as 42 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (24 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information24
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available2
- Fracture2
- Device Dislodged or Dislocated1
- Device Slipped1
- Failure To Adhere Or Bond1
- Material Separation1
Patient problems
- Injury25
- No Code Available5
- Joint Dislocation3
- Pain3
- Swelling3
- Failure of Implant2
- Hemorrhage/Blood Loss/Bleeding2
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING A DECREASED ROM ON THE RIGHT KNEE. A REVISION SURGERY WITH S+N TIBIAL INSERT WAS PERFORMED TO RESOLVE THE ADVERSE EVENT.
Patient problems: Injury
MAUDE report 10720845 ↗InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED DEEP SCAR TISSUE ON RIGHT KNEE. ADVERSE EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.
Patient problems: Injury
MAUDE report 10063678 ↗InjuryMar 30, 2020Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A VERTICAL PATELLAR FRACTURE ON THE LEFT KNEE. THE EVENT WAS DISCOVERED VIA X RAYS WHICH SHOWED THE VERTICAL FRACTURE. THE EVENT WAS RESOLVED.
Patient problems: Injury
MAUDE report 9900940 ↗InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CLINICAL SUBJECT WAS HOSPITALIZED DUE TO A FALL. THE PATIENT SUFFERED FROM WOUND DEHISCENCE DUE TO THE FALL AND SPENT 10 DAYS IN THE HOSPITAL.
Patient problems: Injury
MAUDE report 9832151 ↗InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER SURGERY, RIGHT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 9820367 ↗InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER SURGERY, LEFT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 9795134 ↗InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE.
Patient problems: Injury
MAUDE report 9378648 ↗InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS OF LEFT KNEE.
Patient problems: Injury
MAUDE report 9313364 ↗InjurySep 6, 2019Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT PRESENTED A RIGHT FOOT FRACTURE. ADVERSE EVENT HAS A POSSIBLE RELATION TO DEVICE. NO PROCEDURE DETAILS REPORTED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.
Patient problems: Injury
MAUDE report 8969387 ↗InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY TO WALK, RIGHT KNEE ANKYLOSIS AND SYNOVITIS POST-OPERATIVE. THE EVENT WAS RESOLVED PERFORMING AN UNSPECIFIED SURGICAL PROCEDURE.
Patient problems: Injury
MAUDE report 8897971 ↗InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A FALL WITH WOUND DEHISCENCE.
Patient problems: Injury
MAUDE report 8892475 ↗InjuryAug 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH ELIQUIS DUE TO LOWER EXTREMITY DEEP VEIN THROMBOSIS.
Patient problems: Swelling
MAUDE report 8886073 ↗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 8868007 ↗InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO PULMONARY EMBOLISM. AND TREATED WITH AN UNKNOWN REMEDIAL THERAPY.
Patient problems: Injury
MAUDE report 8867780 ↗InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WITH DECREASED RANGE OF MOTION AND KNEE PAIN. MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2018 TO RESOLVE THIS ISSUE.
Patient problems: Fibrosis
MAUDE report 8834720 ↗InjuryJul 26, 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 8830700 ↗InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS.
Patient problems: Injury
MAUDE report 8830644 ↗InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH HEPARIN DUE TO DEEP VEIN THROMBOSIS.
Patient problems: Injury
MAUDE report 8796502 ↗InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A CLOSED MEDICAL MANIPULATION UNDER ANESTHESIA, DUE TO ARTHROFIBROSIS IN THE RIGHT KNEE.
Patient problems: Injury
MAUDE report 8712744 ↗InjuryMay 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT AFTER KNEE REPLACEMENT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO LIMITED RANGE OF MOTION.
Patient problems: Injury
MAUDE report 8643605 ↗InjuryApr 4, 2019Material Separation; Material Separation
MANIPULATION UNDER ANESTHETIC - AS A CONSEQUENCE OF, KNEE GAVE WAY WHIST PERFORMING SQUATS IN THE POOL, CAUSING SIGNIFICANT PAIN. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.
Patient problems: Pain
MAUDE report 8483565 ↗InjuryMar 20, 2019Unstable; Unstable
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. RIGHT TKR POLY WAS EXCHANGED.
Patient problems: Injury
MAUDE report 8436584 ↗InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD LEFT KNEE INFLAMMATION 3 YEARS AFTER THE SURGERY AND PATIENT WAS GIVEN PREDNISONE.
Patient problems: Inflammation
MAUDE report 8080212 ↗InjuryNov 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT SUFFERED FROM PAIN ON THE RIGHT KNEE. REVISION SURGERY PERFORMED. NO DELAY, ADDITIONAL INJURIES OR BACK UP REPORTED.
Patient problems: Injury
MAUDE report 8066813 ↗InjuryOct 4, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2017 DOCTOR ELECTED TO ASPIRATE 10CC OF BLOOD-TINGED FLUID ON FROM PATIENT'S KNEE JOINT, 12 DAYS LATER DOCTOR INJECTED 20.5MCI OF TC 99M HDP DUE TO PAIN AND SWELLING.
Patient problems: Pain; Swelling
MAUDE report 7934930 ↗
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-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
- 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-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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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