JOURNEY 74022115Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556169919), received between Apr 3, 2017 and Sep 9, 2025 — classified as 24 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY PERFORMED IN (B)(6) 2021, IN WHICH A JOURNEY II BCS FEMUR SIZE 5, A JOURNEY TIBIA SIZE 5, AND A PATELLA 32 X 7.5 POLYETHYLENE 9MM BCS WERE IMPLANTED, THE PATIENT EXPERIENCED INFLAMMATION CAUSED BY A SUSPECTED ALLERGIC REACTION. IT IS CURRENTLY UNKNOWN IF THE PATIENT IS ALLERGIC TO ANY OF THE IMPLANT MATERIALS. ALL ORTHOPEDIC SURGEONS HAVE DECLINED TO ATTEMPT SURGICAL REVISION UNTIL CONFIRMATION OF THE PATIENT¿S POTENTIAL ALLERGY TO THE CURRENT IMPLANTS IS OBTAINED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 23006129 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY ON (B)(6) 2021, DUE TO ARTHRITIS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED LOOSENING. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. 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: Inadequate Osseointegration

  MAUDE report 21541018 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A KNEE INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A JRNY II BCS FEMORAL OXIN RT SZ 5 AND A JOURNEY TIBIA BASE NP RT SZ 3 WERE EXPLANTED, AND A KNEE SPACER WENT IN TO CORRECT THE INFECTION. THERE WAS NO DELAY AND PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Medical device site infection

  MAUDE report 20600244 ↗
• InjuryDec 27, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 WITH A JOURNEY II AND CORI SYSTEM, PATIENT PRESENTED ARTHROFIBROSIS AND POST OPERATIVE STIFFNESS. MANIPULATION UNDER ANESTHESIA WAS SCHEDULED FOR (B)(6) 2022. ADVERSE EVENT HAS NOT BEEN RESOLVED.

  Patient problems: Fibrosis; Foreign Body Reaction; Loss of Range of Motion; Pain

  MAUDE report 16056449 ↗
• InjuryNov 22, 2021Adverse 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 AN UNKNOWN DATE, THE PATIENT PRESENTED WITH RIGHT MEDIAL LIGAMENT LAXITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12857559 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [STUDY ID: (B)(6); SUBJECT: (B)(6)] IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO PAIN IN THE RIGHT KNEE WITH INSTABILITY, AFTER A TKA PROCEDURE. PATIENT WAS HOSPITALIZED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11730239 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DECREASED ROM ON THE RIGHT KNEE. A REVISION SURGERY WITH S+N TIBIAL INSERT WAS PERFORMED TO RESOLVE THE ADVERSE EVENT.

  Patient problems: Injury

  MAUDE report 10719364 ↗
• InjuryOct 16, 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, THE PATIENT EXPERIENCED PAIN AND INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE IMPLANTS, ALTHOUGH THE SURGEON STATED THAT IMPLANTS WERE NOT DEFECTIVE. IT IS UNKNOWN IF EVENT WAS RESOLVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10689472 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS OF RIGHT KNEE REQUIRING SUBSEQUENT ARTHROSCOPY.

  Patient problems: Injury

  MAUDE report 9482615 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATELLOFEMORAL CREPITATION POSTOPERATIVE. THE EVENT WAS RESOLVED PERFORMING AN UNSPECIFIED SURGICAL PROCEDURE AND HOSPITALIZATION.

  Patient problems: Injury

  MAUDE report 8897972 ↗
• InjuryJun 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT FELL AND WAS SCHEDULED TO HAVE AN INSERT SWAP. UPON EXAMINING THE COMPONENTS, THE PHYSICIAN DETERMINED THAT THE IMPLANTS WOULD NOT BE ADEQUATE TO PREVENT THE PATIENT FROM FALLING AGAIN WHILE AMBULATING, THEREFORE THE IMPLANTS WERE REMOVED AND A HINGE LEGION WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8671393 ↗
• InjuryApr 4, 2019Material Separation; Material Separation

  MANIPULATION UNDER ANESTHETIC - AS A CONSEQUENCE OF, KNEE GAVE WAY WHIST PERFORMING SQUATS IN THE POOL, CAUSING SIGNIFICANT PAIN. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8483525 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE, PATIENT EXPERIENCED PAIN IN HIS RIGHT KNEE. NO SIGNS OF NEUROPATHIC PAIN. KNEE WAS WARM AND SWOLLEN. PATIENT REQUIRED HOSPITALIZATION. NO SPECIFIC COMPONENT OF THE TOTAL KNEE SYSTEM WAS ASSESSED AS TO BE THE MAIN COMPLAINED DEVICE.

  Patient problems: Pain

  MAUDE report 8479081 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT ID: (B)(6). IT WAS REPORTED THAT THE PATIENT HAS A RIGHT KNEE BURSITIS. THE CAUSE OF THE BURSA INFLAMMATION IS UNKNOWN. ALSO IS UNKNOWN IF ANY IMPLANT HAS BEEN EXPLANTED TO THE PATIENT OR TREATMENT FOR THE BURSA INFLAMMATION.

  Patient problems: Injury; Joint Swelling

  MAUDE report 8217629 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT NEEDED A SURGICAL PROCEDURE DUE TO PAIN, GENU VARUM AND DIFFICULTY WALKING.

  Patient problems: Injury

  MAUDE report 7520334 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT WAS READMITTED (B)(6) 2015 DUE TO MANIPULATION UNDER ANESTHESIA. THE PATIENT ALSO PRESENTED WITH SWELLING OF THE RIGHT KNEE ON (B)(6) 2016 HOWEVER NO TREATMENT WAS PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069540 ↗
• InjuryNov 23, 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 ANTERIOR KNEE PAIN, PATELLA RESURFACING WAS EXCHANGED DUE TO THIS ISSUE.

  Patient problems: Pain

  MAUDE report 7057210 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THE PATIENT HAD RIGHT KNEE SWELLING, ACUTE RENAL FAILURE AND POSITIVE STAPH AUREUS RIGHT KNEE THAT REQUIRED SURGICAL PROCEDURE.

  Patient problems: Injury

  MAUDE report 6938967 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT DEVELOPED A PRE PATELLAR EFFUSION WHICH WAS LARGER AND DID NOT DIMINISH WITH TIME OR COMPRESSION. THEREFORE A BURSECTOMY WAS PERFORMED.

  Patient problems: Injury; Swelling

  MAUDE report 6829616 ↗
• InjuryAug 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY FOR HIS RIGHT KNEE DUE TO PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6823350 ↗
• InjuryAug 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH RIGHT KNEE EFFUSION AND UNDERWENT A RIGHT KNEE ASPIRATION.

  Patient problems: Inflammation

  MAUDE report 6811297 ↗
• InjuryJul 7, 2017Patient-Device Incompatibility

  IT WAS REPORTED THROUGH (B)(6) CLINICAL TRIAL THAT PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE IN ORDER TO RESOLVE INCREASED RIGHT KNEE PAIN. THE EVENT WAS RESOLVED WITH RESIDUAL EFFECTS ON (B)(6) 2014. STUDY INVESTIGATOR DEEMED THIS EVENT UNRELATED TO STUDY DEVICE AND POSSIBLY RELATED TO STUDY PROCEDURE.

  Patient problems: Pain

  MAUDE report 6693271 ↗
• InjuryJun 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TREATED WITH WEEKLY ANTIBIOTIC THERAPY (BACTRIM DS 800/160 2X1) DUE TO POST-OPERATIVE DRAINAGE OF THE RIGHT KNEE. EVENT WAS DESCRIBED AS NON-SERIOUS, OF MILD SEVERITY, NOT RELATED TO STUDY DEVICE AND POSSIBLY RELATED TO STUDY PROCEDURE AND WAS DEEMED SOLVED.

  Patient problems: Injury; No Code Available

  MAUDE report 6639438 ↗
• InjuryApr 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED FOR A PATELLA RESURFACING AS THE PATIENT COMPLAINED OF PERSISTENT ANTERIOR KNEE PAIN. NONE OF THE ORIGINAL COMPONENTS NEEDED REVISING AT THIS TIME.

  Patient problems: Pain

  MAUDE report 6453650 ↗

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