JOURNEY 74022216Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY TIBIAL BASEPLATE NONPOROUS 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 tibial baseplate is the plastic-and-metal tray used in knee replacement surgery. The 28 reports mostly describe patients having pain, swelling, drainage or infection after surgery, with several needing revision surgery to remove or exchange implants, and one report of an opened inner package that potentially contaminated the implant. No deaths were reported and 27 injuries were. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010554307), received between Aug 7, 2017 and Nov 20, 2024 — classified as 27 injuries, 1 malfunction.
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 (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information18
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available1
- Delivered as Unsterile Product1
- Device Slipped1
- Fracture1
- Material Separation1
- Migration or Expulsion of Device1
Patient problems
- Injury11
- Pain10
- Aspiration/Inhalation2
- Loss of Range of Motion2
- No Code Available2
- Cellulitis1
- Extravasation1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING A TKA, THE INNER PACKAGE OF THE JOURNEY TIBIA BASE NP RT SZ 6 WAS OPEN AND POTENTIALLY CONTAMINATED THE IMPLANT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733016 ↗InjuryAug 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SEPTIC LOOSENING OF IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE FOLLOWING DEVICES: JRNY II CR FEM OX NP RT SZ 7, JOURNEY TIBIA BASE NP RT SZ 6 AND JRNY II CR ISRT XLPE RT SZ 5-6 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 15294157 ↗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 TIBIA BASE NP RIGHT SIZE 6 COMPONENT. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 10624665 ↗InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A REVISION SURGERY WAS DISCUSSED TO BE PERFORMED DUE TO PATIENT PRESENTING PAIN. SURGEON EXPLANTED THE FEMUR, TIBIA AND INSERT WITH MINIMAL BONE LOSS. HE USED J&J REVISION IMPLANTS. THE PATIENT RECEIVED THE PRIMARY SURGERY ON (B)(6) 2019. THE PATELLA WAS LEFT. THE SURGEON COULD NOT CLINICALLY FIND ANY PROBLEMS FOR PATIENT¿S COMPLAINT OF PAIN, EXCEPT FOR A PROBABLE LIMITED POSTERIOR SLOPE ON TIBIA. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Extravasation; Injury; Pain
MAUDE report 10522694 ↗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 9349470 ↗InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SEPSIS ON THE PATIENT. THE DOCTOR REMOVED ALL THE IMPLANTS, DID A WASHOUT AND INSERT A CEMENT SPACER. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 9253254 ↗InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT SEROSANGUINEOUS DRAINAGE FROM MID TKA INCISION WAS NOTICED. THE ADVERSE EVENT WAS RESOLVED BY IRRIGATING AND PERFORMING DEBRIDEMENT.
Patient problems: Injury
MAUDE report 8904426 ↗InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT PRESENTED HYPOXEMIA POST OPERATIVE WHICH REQUIRED HOSPITALIZATION.
Patient problems: Hypoxia
MAUDE report 8824586 ↗InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT CELLULITIS WAS PRESENTED BY PATIENT POST OPERATIVE.
Patient problems: Cellulitis
MAUDE report 8824539 ↗InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT POST OPERATIVE HYPOTENSION REQUIRED HOSPITALIZATION AS RESULT OF THE EVENT.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 8824450 ↗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 8712743 ↗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 8624641 ↗InjuryApr 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD PERSISTENT ANTEROLATERAL KNEE PAIN AFTER TKA RIGHT. LATERAL FACETECTOMY AND LATERAL RELEASE TKA RIGHT WAS PERFORMED WITH NO DEVICE CHANGE.
Patient problems: Pain
MAUDE report 8536066 ↗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 8483561 ↗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 8347855 ↗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 8347843 ↗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 8347715 ↗InjuryJan 10, 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; Pain
MAUDE report 8237417 ↗InjuryDec 26, 2018Insufficient 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: Aspiration/Inhalation; Injury
MAUDE report 8198335 ↗InjuryDec 10, 2018Insufficient 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; Injury; Loss of Range of Motion
MAUDE report 8147111 ↗InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT CAN'T SLEEP AT NIGHT BECAUSE OF THE PAIN. WHEN WALKING HAS PAIN. KNEE IS TURNING BLACK INSIDE.
Patient problems: Pain
MAUDE report 8126070 ↗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 8066799 ↗InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED A QUADRICEP TENDON RUPTURE. ACTION TAKEN: SURGERY/PROCEDURE - REVISION WITH POLY CHANGE, DEBRIDEMENT AND QUAD REPAIR.
Patient problems: No Code Available; Rupture
MAUDE report 7845916 ↗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 7519645 ↗InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT PRESENTED RIGHT KNEE ARTHROFIBROSIS. A MANIPULATION UNDER ANESTHESIA WAS DONE.
Patient problems: Injury
MAUDE report 7470887 ↗
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-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
- 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 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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