JOURNEY 74021153Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556422861), received between Oct 8, 2018 and Oct 17, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO A FEELING OF WRONGNESS A MONTH PRIOR. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE ACL AND PCL WERE TORN. ADDITIONALLY, IT WAS FOUND THAT THE INSERT WAS WORN AND THAT THE FEMORAL COMPONENT WAS HITTING THE TIBIAL BASEPLATE, WHICH CAUSED METALLOSIS. ALL IMPLANTED PRODUCTS WERE EXCHANGED TO LEGION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Damage to Ligament(s); Failure of Implant; Metal Related Pathology

  MAUDE report 17951285 ↗
• InjuryOct 7, 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) 2016, THE CLINICAL SUBJECT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. HOWEVER, IT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12595331 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A TKA REVISION SURGERY WAS PERFORMED FOR SUSPECTED TUMOR, IN ADDITION IT WAS FOUND DURING SURGERY THAT THE INSERT, THE BASE PLATE AND THE FEMORAL COMPONENT HAD SEVERE DAMAGE AND METALLOSIS. THE PRIMARY TKA WAS PERFORMED 4 YEARS EARLIER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Solid Tumor

  MAUDE report 12164288 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRIMARY JOURNEY XR KNEE REPLACEMENT WAS DONE BY ANOTHER SURGEON IN (B)(6) 2020. THEN, THE PATIENT WAS REVISED ON (B)(6) BECAUSE THE PATIENT COMPLAINED OF KNEE PAIN AND COULD NOT FLEX THE KNEE PAST 95 DEGREES AFTER THE INITIAL OPERATION. THE SURGEONS IDENTIFIED THAT THE PROBLEM WAS BECAUSE THE JOINT LINE WAS RAISED BY ABOUT 10 MM AND THE TIBIAL SLOPE WAS DECREASED FROM ABOUT 10 DEGREES TO ZERO.

  Patient problems: Pain

  MAUDE report 11069497 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE, USING A JOURNEY II CR FEM OXONIUM NP RIGHT SIZE 3, THE PATIENT HAD A DEEP VEIN THROMBOSIS AND A PULMONARY EMBOLISM.

  Patient problems: Pulmonary Embolism; Thrombosis; Thrombosis/Thrombus

  MAUDE report 10721869 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ORTHOPEDIC SURGERY HAD TO BE PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE. REHABILITATION THERAPY FOLLOWING THE TKA WITH JOURNEY II CR TKS WAS PERFORMED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 10154010 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM RIGHT KNEE ARTHROFIBROSIS AFTER A TKR. THE EVENT WAS RESOLVED VIA MUA, WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9832133 ↗
• InjurySep 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE DUE TO STIFFNESS. THERE IS ONLY INFORMATION OF THE FEMORAL COMPONENT AND TIBIAL BASE COMPONENT BEING INVOLVED.

  Patient problems: Injury

  MAUDE report 9068748 ↗
• InjuryAug 8, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE SURGEON HAD AN UNHAPPY PATIENT WHICH RECEIVED THE PRIMARY SURGERY FROM ANOTHER SURGEON. PATIENT COMPLAINT OF INSTABILITY. SURGEON DID A FLICKERGRAM ON THE PATIENT TO SEE IF THE FEMORAL COMPONENT WAS LOSE. THE RESULT WAS NOT CONCLUSIVE SO THE SURGEON PERFORMED A SURGERY TO INVESTIGATE.

  Patient problems: Injury

  MAUDE report 8876474 ↗
• InjuryJul 31, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT KNEE PAIN AND STIFFNESS AND IT WAS RESOLVED WITH A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8845179 ↗
• 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 8727650 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION AND ACL RUPTURE. ALL IMPLANTS WERE REPLACED.

  Patient problems: Rupture

  MAUDE report 8358706 ↗
• InjuryOct 8, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO LOOSENING OF TIBIAL BASEPLATE AND FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 7945376 ↗

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