JOURNEY 74022117Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556170014), received between Jul 6, 2017 and Jun 22, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED A CHRONIC INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A JRNY II BCS FEMORAL OXIN RT SZ 7, JOURNEY TIBIA BASE NP RT SZ 7, JRNY II BCS XLPE ART ISRT SZ 7-8 RT 10MM AND A GNS II RESURF PAT 35MM WERE EXCHANGED. DEBRIDEMENT OF KNEE JOINT UNDERTAKEN AND A LEGION COBALT CHROME FEMUR AND ALL POLY TIBIA IMPLANTED WITH ANTIBIOTIC CEMENT TO TREAT THE INFECTION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25572824 ↗
• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTED KNEE. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) JRNY II BCS FEMORAL OXIN RT SZ 7, ONE (1) JRNY II BCS CNSTRD ART ISRT RT 5-6 15M, ONE (1) GNS II RESURF PAT 35MM AND ONE (1) JOURNEY TIBIA BASE NP RT SZ 6 WERE REMOVED. A SPACER WAS IMPLANTED TO HELP CLEAR UP ANY INFECTION WITH A PLAN TO IMPLANT FUTURE COMPONENTS, ONCE THE HEALTH OF THE PATIENT'S KNEE CORRECTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21829794 ↗
• 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. DURING THE SURGERY THE RUPTURE WAS REPAIRED. IT IS 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 21539867 ↗
• InjuryJul 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 HAD BEEN PERFORMED ON (B)(6) 2022 THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE TO ADDRESS THIS ADVERSE EVENT. THE SURGEON REPLACED THE EXPLANTED DEVICES WITH NEW TIBIA COMPONENT, AND A COCR LEGION FEMUR CEMENTED IN WITH ANTIBIOTIC CEMENT TO HELP WITH INFECTION. THE PATIENT LEFT THE SURGICAL CASE IN GOOD HEALTH. NO INJURY TO THE PATIENT, NO DELAY IN CASE, NO FURTHER MEDICAL HISTORY AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 17368096 ↗
• 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 10522687 ↗
• InjuryOct 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING.

  Patient problems: Injury

  MAUDE report 9235239 ↗
• 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 8536027 ↗
• InjuryDec 2, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING AND ONGOING PAIN.

  Patient problems: Injury

  MAUDE report 8123199 ↗
• 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 8066716 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. FEMORAL COMPONENT AND INSERT WERE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 7875131 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO BONE AND TENDON PAIN IN THE RIGHT KNEE. TENDON WAS REMOVED DURING THIS PROCEDURE.

  Patient problems: Pain

  MAUDE report 7519652 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ARTHROCENTESIS TREATMENT WAS PERFORMED DUE TO KNEE PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7108687 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISED WAS PERFORMED DUE TO STIFFNESS AFTER A RIGHT TKA.

  Patient problems: Injury

  MAUDE report 7075093 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND SWELLING. KNEE PAIN/SWELLING AND RANGE OF MOTION IMPROVED AFTER THIS REVISION.

  Patient problems: Pain; Swelling

  MAUDE report 7073293 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO FLEXION CONTRACTURE. IT WAS ALSO REPORTED THE PATIENT HAD FALLEN DOWN STAIRS AND HAD SWELLING AND PAIN.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 7069952 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SURGICAL PROCEDURE WAS PERFORMED TO RESOLVE KNEE EFUSSION AND PAIN.

  Patient problems: Injury; Joint Swelling

  MAUDE report 6978097 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ASPIRATION.

  Patient problems: Aspiration/Inhalation

  MAUDE report 6860423 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING TOTAL KNEE REPLACEMENT SURGERY PATIENT HAD A KNEE INFECTION AND EFFUSION. PATIENT WAS HOSPITALISED AND ADMINISTERED WITH IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 6837893 ↗
• InjuryJul 6, 2017Insufficient Device Problem Information

  IT WAS REPORTED TO US THROUGH RETROSPECTIVE CLINICAL TRIAL THAT PATIENT UNDERWENT OTHER CONSERVATIVE APPROACH IN ORDER TO SOLVE RIGHT KNEE SWELLING. OUTCOME OF THIS EVENT IS RESOLVED ON (B)(6) 2013 AND SEVERITY WAS DEEMED AS MILD.

  Patient problems: Joint Swelling

  MAUDE report 6688843 ↗

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