JOURNEY 74022222Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010554383), received between Sep 30, 2019 and Feb 5, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON AN UNKNOW DATE, ONE (1) JOURNEY TIBIA BASE NP LT SZ 2 BECAME LOOSE. A REVISION SURGERY WAS PERFORMED ON (B)(6)2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Joint Laxity

  MAUDE report 18640433 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(4) 2022, THE PATIENT COMPLAINED OF LATERAL TIBIAL KNEE PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JOURNEY TIBIA BASE NP LT SZ 2 WAS EXCHANGED. THE IMPLANTS WERE NOTED "WELL FIXED" AND HAD TO DILIGENTLY EXTRACT DURING THE REMOVAL PROCESS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 18141138 ↗
• InjuryOct 4, 2022Material Erosion; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Material Erosion; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THATK, AFTER TKA PROCEDURE ON (B)(6) 2020, THE PATIENT GOT PCL MALFUNCTION DUE TO FALLING AND FELT IMPINGEMENT BETWEEN FEMUR AND TIBIA. IN ADDITION, DURING X-RAYS IT WAS CONFIRMED THE JRNY II CR FEM OX NP LT SZ 3 AND JRNY II XR BASEPLATE SZ 2 LT WERE WEAR. A REVISION SURGERY WILL BE PERFORMED BUT THE DATE IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Fall; Loss of Range of Motion

  MAUDE report 15535486 ↗
• InjuryDec 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROPLASTY SURGERY, A METAL FRAGMENT WAS FOUND IN PATIENT'S INCISION. THE METAL FRAGMENT WAS SUCCESSFULLY REMOVED. IT IS UNKNOWN WHICH PRODUCT THIS METAL FRAGMENT CAME FROM AS THERE WERE NO BREAKAGE ON SURGICAL INSTRUMENTS; THEREFORE, IT MIGHT HAVE COME FROM EITHER JRNY II BCS FEMORAL OXIN LT SZ 3 OR JOURNEY TIBIA BASE NP LT SZ 2. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911898 ↗
• InjuryNov 19, 2021Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, AFTER A JOURNEY TIBIA BASE NP LEFT SIZE 2 WAS OPENED AND USED IN THE PATIENT, IT WAS NOTICED THAT THE STERILE PACKAGING HAD BEEN DAMAGED, THE PACKAGING HAD BEEN CUT WITH A SHARP INSTRUMENT THROUGH ALL THE LAYERS OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843985 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. UNKNOWN IF OCCURRED A SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11391146 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA HAD TO BE PERFORMED ON THE LEFT KNEE. IT IS UNKNOWN THE REASON OF THE ADVERSE EVENT. THE PATIENT OUTCOME WAS SUCCESSFULLY RESOLVED. NO INJURY NOR DELAY HAS BEEN REPORTED.

  Patient problems: Injury

  MAUDE report 10166234 ↗
• InjuryMay 25, 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 WITH A JOURNEY II SYSTEM, THE PATIENT HAD JOINT INSTABILITY. A REVISION SURGERY WAS PERFORM TO TREAT THIS ADVERSE EVENT. THE IMPLANTS ARE NOT CONSIDERED DEFECTIVE BY THE SURGEON: IT WOULD HAVE BEEN BETTER TO IMPLANT A 13 MM INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10085820 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THREE MONTHS AFTER PRIMARY LEFT-SIDED TKA SURGERY WITH JOURNEY II CR TOTAL KNEE SYSTEM, THE CLINICAL SUBJECT PRESENTED AN UNSPECIFIED ADVERSE EVENT WHICH WAS TREATED AND RESOLVED VIA MANIPULATION UNDER ANESTHESIA. THE PATIENT RECOVERED.

  Patient problems: Injury

  MAUDE report 10073291 ↗
• InjuryApr 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE YEAR AFTER PRIMARY SURGERY, REVISION SURGERY HAD TO BE PERFORMED DUE TO DISLOCATION. THE JOURNEY TIBIAL BASEPLATE NONPOROUS LEFT SIZE 2 WAS EXCHANGED. DR. STATED THAT THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Joint Dislocation

  MAUDE report 9953460 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A CONTRACTURE ON THE LEFT KNEE. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842219 ↗
• InjuryOct 21, 2019Unstable; Unstable

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE PATIENT EXHIBITED DECREASED RANGE OF MOTION IN LEFT KNEE WITH INSTABILITY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE POLYETHYLENE AND TIBIAL COMPONENT.

  Patient problems: Injury

  MAUDE report 9216077 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE IMPLANTATION, A FOREIGN PARTICLE WAS FOUND, AND IT WAS PICKED UP FROM THE PATIENT BODY. IT WAS UNKNOWN IF THE PARTICLE WAS CAUSED BY THE INSTRUMENTS OR IMPLANTS.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9137594 ↗

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, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY 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, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112