JOURNEY 74022118Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556170069), received between Jul 6, 2017 and Mar 6, 2025 — classified as 1 death, 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED RIGHT TKA SURGERY ON (B)(6) 2019, DUE TO DEGENERATIVE JOINT DISEASE, AN INTRA OPERATIVE MEDIAL COLLATERAL LIGAMENT (MCL) RUPTURE OCCURRED. IT IS UNKNOWN HOW THIS EVENT WAS TREATED. IT IS ALSO UNKNOWN HOW WAS THE SURGERY COMPLETED AND IF THERE WAS A DELAY. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Damage to Ligament(s)

  MAUDE report 21537480 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 21318234 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT HAS EXPERIENCED ONGOING PAIN A SWELLING. THIS ADVERSE EVENT HAS BEEN TREATED BY MULTIPLE APPROACHES, INCLUDING A KNEE ASPIRATION AND STEROID INJECTION ON 31-JAN-2018. BONE SCANS CONFIRMED LARGE JOINT EFFUSION AND PATELLAR MALTRACKING, FOR WHICH, ON (B)(6) 2018, BILATERAL KNEE RELEASE WAS PERFORMED TO ADDRESS THIS KNEECAP POSITIONING PROBLEM. A SECOND KNEE ASPIRATION WAS PERFORMED ON (B)(6) 2019. PATIENT'S PAIN AND SWELLING IS STILL ONGOING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19121440 ↗
• MalfunctionJun 19, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, ALTHOUGH THE EXTERNAL BOX OF THE JRNY II BCS FEMORAL OXIN RT SZ 8 IMPLANT WAS INTACT, THE PLASTIC WRAP WAS NOT SEALED; THE IMPLANTED CAME STRAIGHT IN THE BOX. THIS HAPPENED DURING A TKA SURGERY, BUT IT WAS NOTICED ON TIME, SO THERE WAS NOT ANY EFFECT ON THE OPERATION. THERE WAS ANOTHER PROSTHESIS ON STOCK AND IT WAS USED AFTER A 2-MIN DELAY. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741320 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 9482463 ↗
• 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 8643606 ↗
• InjuryMay 8, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ACCORDING TO PHYSICIAN DEEMED IMPLANTS TO BE LOOSE. REMOVED THEM AND REPLACED THEM WITH LEGION. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8593767 ↗
• DeathSep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT'S DECEASE WAS REPORTED 3 MONTHS AFTER RIGHT TOTAL KNEE REPLACEMENT.

  Patient problems: Death

  MAUDE report 7911108 ↗
• InjurySep 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SERIOUS INJURY DURING CLINICAL STUDY IN WHICH THERE WAS INFECTION IN RIGHT KNEE. RIGHT PERI-PROSTHETIC INFECTION WITH I&D X 2 AND POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 7858731 ↗
• InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO SWELLING OF RIGHT KNEE .

  Patient problems: Joint Swelling

  MAUDE report 7302364 ↗
• InjuryOct 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH RIGHT KNEE GENICULAR NEURALGIA AND RIGHT KNEE PAIN. THE SURGEON PERFORMED PROCEDURES: FLUOROSCOPIC GUIDANCE FOR NEEDLE REPLACEMENT, RIGHT SUPEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT SUPEROLATERAL GENICULAR BRANCH OF THE FEMORAL NERVE BLOCK, RIGHT INFEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT MEDIAL GENICULAR BRANCH FROM THE VASTUS INTERMEDIUS NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 6906919 ↗
• InjurySep 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT PRESENTED EFFUSION IN RIGHT KNEE WITH PAIN THEREFORE AN ASPIRATION OF THE RIGHT KNEE WAS PERFORMED AS TREATMENT.

  Patient problems: Injury

  MAUDE report 6867481 ↗
• InjurySep 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS PRESENT AT EMERGENCY ROOM WITH COMPLAINTS OF REDNESS, PAIN AND SWELLING OF RIGHT KNEE. PATIENT WAS HOSPITALISED FOR INFECTION EVALUATION. PATIENT WAS NOT DIAGNOSED WITH INFECTION, PROPHYLAXIS TREATMENT GIVEN (ABCEF 1G IV).

  Patient problems: Erythema; Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 6841026 ↗
• InjuryAug 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH INFECTION IN THE RIGHT KNEE. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE ANTI-BIOTIC SPACER WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 6793621 ↗
• InjuryAug 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH RIGHT KNEE SYNOVITIS AND PAIN AND WAS ADMINISTERED PREDNISONE.

  Patient problems: Inflammation; Pain

  MAUDE report 6773030 ↗
• InjuryJul 6, 2017Insufficient Device Problem Information

  IT WAS REPORTED TO US THROUGH RETROSPECTIVE CLINICAL TRIAL THAT PATIENT REQUIRED REMEDIAL THERAPY AND OTHER CONSERVATIVE APPROACH DUE TO RIGHT KNEE STIFFNESS. OUTCOME OF THIS EVENT IS UNKNOWN AND SEVERITY WAS DEEMED MILD.

  Patient problems: No Code Available

  MAUDE report 6688846 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5