JOURNEY 74021156Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556422830), received between Apr 20, 2018 and Mar 9, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ALL THE IMPLANTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24545110 ↗
• InjuryDec 13, 2024Adverse 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)(6)2018, THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT THAT WAS TREATED BY A REVISION SURGERY ON (B)(6)2019, IN WHICH THE JRNY II CR FEM OX NP RT SZ 6, THE GEN II 7.5MM RESUR PAT 35MM, THE JRNY II CR ISRT XLPE RT SZ 3-4 12MM AND THE JOURNEY TIBIA BASE NP RT SZ 4 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20922026 ↗
• InjuryDec 20, 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)(6) 2016 FOR A CLINICAL STUDY (JOURNEY II CR - 13-4049-06), PATIENT EXPERIENCED KNEE PAIN ON 02-MAR-2020. THIS ADVERSE EVENT WAS TREATED WITH RADIOFREQUENCY ABLATION OF GENICULAR NERVED AND SAPHENOUS NERVE BLOCK. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 18365453 ↗
• InjuryMar 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) -2018, THE PATIENT EXPERIENCED A CONTRACTURE ON (B)(6) 2019, APPROXIMATELY ONE YEAR AFTER SURGERY. A NON-INVASIVE JOINT MOBILIZATION PROCEDURE WAS PERFORMED ON (B)(6) 2019, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020.

  Patient problems: Loss of Range of Motion

  MAUDE report 16570456 ↗
• InjuryFeb 4, 2022Adverse 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 ON (B)(6) 2019 WITH A JOURNEY II XR SYSTEM, THE CLINICAL SUBJECT EXPERIENCED STIFFNESS IN THE KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXPLANT THE SYSTEM. THE CURRENT HEALTH STATUS OF THIS CLINICAL SUBJECT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 13453427 ↗
• InjuryMay 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED A LOOSE PATELLA COMPONENT AND SWELLING AT THE SURGERY SITE. AFTER OBTAINING A CT SCAN, THE SURGEON NOTICED THAT FEMORAL COMPONENT LOOKED DIFFERENT AND INVESTIGATED THE PATIENT CHART FOR IMPLANT STICKERS FROM THE DAY OF SURGERY. AT THIS TIME IT WAS DISCOVERED THAT THE IMPROPER FEMORAL COMPONENT WAS IMPLANTED. A JOURNEY II CR FEMORAL COMPONENT HAD BEEN MISTAKENLY IMPLANTED WITH A LEGION CR INSERT, GENESIS II TIBIAL COMPONENT AND GENESIS II PATELLA. THE PATIENT HAS BEEN SCHEDULED FOR A REVISION SURGERY ON (B)(6) 2021 TO TREAT THIS PROBLEM. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 11798840 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT 3 YEARS AFTER A TKA SURGERY WITH JORUNEY II CR FEM OXINIUM, WAS FOUND A CLOSED NON-DISPLACED FRACTURE OF RIGHT PATELLA, IT WAS TREATED WITH A BRACE KNEE IMMOBILIZER. THE PATIENT OUTCOME IS UNKNOWN; NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bone Fracture(s); No Information

  MAUDE report 10623211 ↗
• InjuryMay 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY IN WHICH A JOURNEY II CR FEMORAL COMPONENT WAS IMPLANTED, THE CLINICAL SUBJECT PRESENTED POST-OPERATIVE STIFFNESS AND PAIN. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT HAS RECOVERED.

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 10021216 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9900921 ↗
• InjuryDec 5, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STIFFNESS AND PAIN FROM THE CUSTOMER.

  Patient problems: Injury

  MAUDE report 9418518 ↗
• 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 8897959 ↗
• 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 8868034 ↗
• InjuryJun 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ARTHROSCOPY DUE TO PERSISTENT CLUNKING AND POPPING.

  Patient problems: Injury

  MAUDE report 8746875 ↗
• InjuryJun 29, 2019Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking

  IT WAS REPORTED THAT RIGHT KNEE STIFFNESS WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 8746770 ↗
• InjurySep 25, 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 7908159 ↗
• InjuryJul 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DUE TO RIGHT KNEE INFLAMMATION THE PATIENT HAS BEEN GIVEN MEDICATIONS SUCH AS VICODIN AND PREDNISONE.

  Patient problems: Inflammation

  MAUDE report 7691054 ↗
• InjuryApr 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A REVISION SURGERY IS TENTATIVELY SCHEDULED DUE TO FEMORAL LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 7446876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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