JOURNEY 74022213Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 03596010554277), received between Nov 30, 2017 and Jun 10, 2025 — classified as 47 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Loosening 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) 2012, THE PATIENT EXPERIENCED PAIN. AN X-RAY APPEARED TO INDICATE THAT THE TIBIAL COMPONENT WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURNEY TIBIA BASE NP RT SZ 3 WAS CONFIRMED LOOSE AND WAS EASILY REMOVED, AS WELL AS THE UNKNOWN JOURNEY FEMORAL COMPONENT AND UNKNOWN JOURNEY INSERT. THE IMPLANTS WERE REPLACED WITH A LEGION REVISION SYSTEM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22175156 ↗
• InjuryNov 6, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A PROSTHETIC FAILURE WHEN SHE WAS GETTING OUT OF THE CAR ON (B)(6) 2023. THE PATIENT DESCRIBED IT AS A BASE PLATE FRACTURE, ACCOMPANIED WITH IMMEDIATE SWELLING AND DISCOMFORT. X-RAYS WERE TAKEN THE FOLLOWING DAY, ON (B)(6) 2023, AND THE PATIENT WAS SCHEDULED FOR REVISION SURGERY THAT WAS PERFORMED ON (B)(6) 2023. THE PATIENT REPORTED A COMPLICATE RECOVERY AFTER THE REVISION SURGERY, WHICH RESULTED IN TWO (2) DAYS OF HOSPITALIZATION, DUE TO NAUSEA, VOMITING AND LOW BLOOD PRESSURE. PATIENT'S CURRENT HEALTH STATUS IS HEALTHY, WITH NO CHRONIC ISSUES OTHER THAN CONTINUED STIFFNESS/TIGHTNESS IN THE KNEE JOINT, POST-SURGERY.

  Patient problems: Discomfort; Failure of Implant; Joint Dislocation; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 18078960 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL TKR HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT PRESENTED RIGHT TIBIAL PAIN. BONE SCAN REPORTED THAT THE TIBIA WAS "HOT" AND LOOSE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO REMOVE THE TIBIAL INSERT AND BASEPLATE, AND A NEW JOURNEY+LEGION TIBIAL INSERT, BASEPLATE, STEM AND RESURFACED PATELLA WERE IMPLANTED. NO PATIENT DETAILS OR X-RAYS AVAILABLE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Inflammation; Pain

  MAUDE report 16792441 ↗
• InjuryApr 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY TIBIA BASE NP RT SZ 3 WAS OPENED FOR A LEFT KNEE. THE TIBIAL BASEPLATE WENT IN AND THE SURGEON REALIZED IT WAS THE WRONG SIDE. THIS WAS CORRECTED BY OPENING AND IMPLANTING THE CORRECT SIDE IMPLANTS. THIS SITUATION RESULTED IN A FRACTURED TIBIA; SCREWS WERE IMPLANTED TO CORRECT THE FRACTURE. NO SIGNIFICANT DELAYS WERE REPORTED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 14068275 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT, AFTER A NAVIO-ASSISTED TKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY II CR SYSTEM ON (B)(6) 2018, THE CLINICAL SUBJECT EXPERIENCED A PERIPROSTHETIC INFECTION. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2019 TO EXPLANT THE FEMORAL, TIBIAL, INSERT AND PATELLAR COMPONENTS. THE PROBLEM IS NOW RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 12111620 ↗
• MalfunctionJun 22, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II BCS XLPE ART ISRT SIZE 3-4-RT 15 MM ((B)(4)) WAS NOT ABLE TO BE FULLY SEAT INTO JOURNEY TIBIA BASEPLATE NP RT SZ 3 ((B)(4)), A 0.5 MM GAP BETWEEN THE BASEPLATE WAS LEFT AND TWO DENTS ON ANTERIOR SIDE OF INSERT WERE DEFORMED BY INSERTER. SURGERY WAS COMPLETED WITH THE SAME DEVICES BECAUSE THERE WAS NO SPARE DEVICES AVAILABLE. THIS PROBLEM CAUSED A LESS THAN 30 MIN SURGERY DELAY. PATIENT WAS REPORTED TO BE HARMED BUT IT IS UNKNOWN HOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038926 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ADHESIONS IN THE RIGHT KNEE, SECONDARY TO TOTAL KNEE ARTHROPLASTY, 90 DEGREES OF MOTION. EXAMINATION AND MANIPULATION OF THE KNEE UNDER ANESTHESIA WAS PERFORMED AND THE OUTCOME REPORTED WAS AS "RESOLVED".

  Patient problems: Loss of Range of Motion

  MAUDE report 10422845 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CELLULITIS ON THE RIGHT KNEE AND LEG HAD PRESENTED. PATIENT DEVELOPED REDNESS AND SWELLING OF THE LEG. ADMITTED TO HOSPITAL FOR ANTIBIOTICS. EVENTUALLY RESOLVED WITHOUT LONG TERM PROBLEMS. HOME PHYSICAL THERAPY AND MEDICATION WERE PRESCRIBED FOR TREATMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Joint Swelling

  MAUDE report 10342328 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE DEVICES MAY HAVE CONTRIBUTED TO CAUSE CEREBRAL VASCULAR ACCIDENT ON PATIENT. THE PATIENT NEEDED HOSPITALIZATION AND MEDICATION DUE TO THE REPORTED EVENT. PATIENT WAS GIVEN TPA, AND WAS TRANSFERRED TO PATIENT REHABILITATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Vascular System (Circulation), Impaired

  MAUDE report 10279972 ↗
• InjuryJun 18, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PROCEDURE, A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF BONE AND PAIN MADE BY THE PATIENT FALLING. THE REVISION SURGERY WAS NOT CAUSED BY SMITH & NEPHEW DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 10167314 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS ON THE RIGHT KNEE JOINT. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842196 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED CELLULITIS IN THE RIGHT LOWER EXTREMITY. THE EVENT WAS TREATED VIA MEDICATION AND MEDICAL INTERVENTION TO PREVENT A LIFE-THREATENING CONDITION IN THE SUBJECT.

  Patient problems: Unspecified Infection

  MAUDE report 9842156 ↗
• 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 9832153 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION WAS PERFORMED BECAUSE THE PATIENT JUMPED OFF A HORSE AND FELL ON FROZEN GROUND ON THE RIGHT KNEE WITH THE PROSTHESIS. DURING THE REVISION, THE TIBIAL BASEPLATE COMPONENT SHOWED EXCELLENT CEMENT ADHERENCE. THE TIBIAL BASEPLATE AND ARTICULAR INSERT WERE REVISED AS PLANNED.

  Patient problems: Injury

  MAUDE report 9587336 ↗
• InjuryJan 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT RIGHT KNEE. PATIENT WAS HEALTHY AND THE REASON FOR REVISION WAS THE PATIENT JUMPED OFF A HORSE AND FELL ON FROZEN GROUND ON HIS RIGHT KNEE. TIBIAL BASEPLATE AND ARTICULAR INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9580203 ↗
• 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 9485151 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD BILATERAL SURGERY 8 YEARS AGO, AND HER ROM IS REDUCED. PAIN AND INSTABILITY ARE ALLEGED IN BOTH KNEES. REVISION FOR THE RIGHT KNEE WAS PERFORMED ON (B)(6) 2019. REVISION SURGERY FOR THE LEFT IS NOT SCHEDULED YET.

  Patient problems: Pain

  MAUDE report 9331792 ↗
• InjuryOct 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFENING.

  Patient problems: Injury

  MAUDE report 9235256 ↗
• InjuryOct 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFENING.

  Patient problems: Injury

  MAUDE report 9235255 ↗
• 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 8897975 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL KNEE ANKYLOSIS AND EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834605 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY PATIENT HAD RIGHT KNEE TOTAL ANKYLOSIS AND WAS RESOLVED THROUGH HOSPITALIZATION AND A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834593 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO RIGHT TOTAL KNEE ANKYLOSIS.

  Patient problems: Injury

  MAUDE report 8830525 ↗
• InjuryJun 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED A NON-DISPLACED TIBIAL PLATEAU LONGITUDINAL FRACTURE ALONG TIBIAL BASEPLATE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8725683 ↗
• InjuryJun 16, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND MID FLEXION INSTABILITY.

  Patient problems: Pain

  MAUDE report 8702655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, 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
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112