JOURNEY 74022225Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010554338), received between Apr 27, 2017 and May 29, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING OF THE FEMUR AND THE TIBIA COMPONENTS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS FEMORAL OXIN LT SZ 6, GNS II RESURF PAT 35MM, JOURNEY TIBIA BASE NP LT SZ 5 AND JRNY II BCS CNSTRD ART ISRT 5-6 LT 9M WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 22107197 ↗
• InjuryJan 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT, AFTER A PRIMARY TOTAL KNEE SURGERY PERFORMED ON (B)(6) 2020, THE PATIENT SUFFERED TIBIAL SUBSIDENCE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT WHERE THE TIBIAL BASEPLATE, TIBIAL INSERT AND PATELLA WERE EXCHANGED. DURING THE PROCEDURE, IT WAS FOUND THAT THE PATELLA WAS LOOSE AND THE INTEGRITY OF ONE OF THE PEGS APPEARED TO BE COMPROMISED, BUT THE PATELLA APPEARED TO HAVE CEMENT ADHERED. THE TIBIA HAD SUBSIDED, BUT APPEARED TO HAVE CEMENT ADHERED. IN ADDITION, IT IS SUSPECTED THAT THE PATIENT WAS NON-COMPLIANT WITH RECOMMENDED ACTIVITIES, AND IT IS SUSPECTED THAT PERFORMED HIGH-IMPACT ACTIVITIES. PATIENT CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 16184831 ↗
• InjuryJan 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND LOOSENING. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13212707 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT HAD A TOTAL KNEE REPLACEMENT 3 YEAR AGO. PATIENT SUFFERED FROM A STIFF KNEE AND LIMITED RANGE OF MOTION 20 DEGREE - 90 DEGREE AND OVERSTUFFED PATELLA FEMORAL JOINT, THEREFORE PATIENT HAD A REVISION SURGERY, WHERE SURGEON REMOVED THE PATELLA, FEMORAL, TIBIAL INSERT AND TIBIAL BASEPLATE FROM PRIMARY SURGERY. SURGEON NOTICED THE PATELLA WAS NOT RESECTED ENOUGH, WHICH CAUSE OVER STUFFING. SURGEON ACHIEVED A RANGE OF MOTION FROM 0 DEGREES - 120 DEGREES RANGE OF MOTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11408622 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 21 MONTHS AGO THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FOR HER LEFT KNEE AND SHE IS STILL IN INCREDIBLE PAIN, IT OFTEN FEELS VERY WARM AND VERY TIGHT. THERE IS A LARGE INDENTATION ON THE BOTTOM LEFT OF HER KNEE, AND A "KNIFE STABBING" AND "OUT OF PLACE" SENSATION. THE DOCTOR SAID IT WAS THE IMPLANT OPENING UP WHEN BENT. THE PAIN IS OFTEN BELOW THE KNEECAP. THE PATIENT IS USING A PATELLA BRACE, KINESIO TAPE, PHYSICAL THERAPY AND PUTTING ICE ON THE KNEE.

  Patient problems: Pain

  MAUDE report 10199443 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Injury

  MAUDE report 9711226 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 9484081 ↗
• InjuryOct 31, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TIBIAL LOOSENING. ALL THE IMPLANTS WERE REMOVED EXCEPT THE PATELLA.

  Patient problems: Injury

  MAUDE report 9263858 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED CELLULITIS OF THE LEFT LOWER EXTREMITY. THE EVENT WAS TREATED VIA REMEDIAL THERAPY (DRUG/TRANSFUSION).

  Patient problems: Unspecified Infection

  MAUDE report 9255814 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO PULMONARY EMBOLISM. AND TREATED WITH AN UNKNOWN REMEDIAL THERAPY.

  Patient problems: Injury

  MAUDE report 8867775 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT LOWER EXTREMITY SWELLING AND CELLULITIS AND WAS RESOLVED WITH UNSPECIFIED REMEDIAL THERAPY.

  Patient problems: Cellulitis; Swelling

  MAUDE report 8834599 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 8830643 ↗
• InjuryJul 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD EFFUSIONS A YEAR AFTER PRIMARY TKA AND A UNSPECIFIED SURGERY WAS PERFORMED AS TREATMENT.

  Patient problems: Injury

  MAUDE report 8766062 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD DIFFICULT REHABILITATION. PATIENT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534358 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD KNEE EFFUSION AND REQUIRED AN ASPIRATION.

  Patient problems: Aspiration/Inhalation; Injury

  MAUDE report 8519023 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT LEFT KNEE ARTHROFIBROSIS. TREATMENT: ASPIRATION AND CLOSED MANIPULATION.

  Patient problems: Fibrosis

  MAUDE report 8493802 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TKA PATIENT HAS ONGOING PAIN AND SWELLING AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8305477 ↗
• InjuryOct 1, 2018Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN IN THE KNEE. NO EVIDENCE OF INFECTION WAS FOUND. LAXITY OF THE COMPONENTS WAS PRESENT MOST NOTABLY IN FULL FLEXION. FEMORAL, TIBIAL AND ARTICULAR DEVICES WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 7924167 ↗
• InjurySep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT TKA ANKYLOSIS AND EVENT WAS RESOLVED IN CLOSED MANIPULATION UNDER ANESTHESIA FOR WHICH SUBJECT WAS HOSPITALIZED.

  Patient problems: Injury

  MAUDE report 7912786 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TWO STEP REVISION SURGERY WAS PERFORMED DUE TO A PERI-PROSTHETIC JOINT INFECTION IN LEFT KNEE. IN FIRST STEP OF THE REVISION SURGERY, ON (B)(6) 2017, PATELLAR COMPONENT AND ARTICULAR INSERT WERE EXPLANTED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. AND ON (B)(6) 2017 THE TOTAL KNEE WAS REVISED TO PERFORM A REIMPLANTATION OF DEVICES.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7892000 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED LEFT KNEE FOR EXCISION OF HYPERTROPHIC SCAR.

  Patient problems: Pain

  MAUDE report 7389870 ↗
• InjuryNov 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FURTHER ON IT WAS CLARIFIED THAT PATIENT UNDERWENT TOTAL KNEE EXCHANGE WITH REVISION OF ALL COMPONENTS, RATHER THAN JUST THE POLY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7057905 ↗
• InjuryOct 18, 2017Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF TOTAL LEFT KNEE ARTHROPLASTY WITH EXCHANGE OF TIBIAL BASEPLATE AND ARTICULAR INSERT DUE TO PAINFUL LEFT KNEE LOOSENING OF TIBIAL INSERT.

  Patient problems: Failure of Implant

  MAUDE report 6957324 ↗
• InjuryOct 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR MONTHS AFTER A LEFT TKA THE PATIENT REQUIRED A LEFT KNEE MANIPULATION UNDER ANESTHESIA BECAUSE HE HAD DIFFICULTY REGAINING HIS PREOPERATIVE RANGE OF MOTION.

  Patient problems: No Code Available

  MAUDE report 6950384 ↗
• InjuryApr 27, 2017Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  REVISION OF TIBIA COMPONENT WAS PERFORMED DUE TO LOOSENING.

  Patient problems: Failure of Implant; No Information

  MAUDE report 6527083 ↗

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-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-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-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