JOURNEY 74023261Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010555205), received between Nov 24, 2017 and Dec 30, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Break” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2013, THE PEG OF THE JOURN ART INS BCS STD 5-6 LT 9 FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE FRACTURED IMPLANT AND REPLACE IT FOR S+N IMPLANTS. THE PATIENT IS STILL EXPERIENCING PAIN AND DISCOMFORT AFTER THIS REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23927746 ↗
• InjurySep 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED A BREAKAGE OF THE JOURN ART INS BCS STD 5-6 LT 9. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURN ART INS BCS STD 5-6 LT 9 WAS REPLACED AND THE PATELLA WAS RESURFACED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23001237 ↗
• InjuryJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A POST BREAKAGE OF THE INSERT, WHICH CAUSED PAIN, SWELLING AND INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURN ART INS BCS STD 5-6 LT 9 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 22293142 ↗
• InjuryFeb 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2006, THE PATIENT EXPERIENCED THE BREAKAGE OF THE ORIGINAL IMPLANT POST. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE JOURN ART INS BCS STD 5-6 LT 9 WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21446022 ↗
• InjuryJul 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011 WITH A JOURNEY BCS SYSTEM, THE PATIENT EXPERIENCED PAIN AND FEMOROTIBIAL DISLOCATION AFTER A FALL ON (B)(6) 2023. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. INTRAOPERATIVELY, IT WAS NOTICED THAT THE JOURN ART INS BCS STD 5-6 LT 9 WAS BROKEN. AS A CONSEQUENCE, THE WHOLE CONSTRUCT HAD TO BE CHANGED. THE PATIENT IS IN GOOD HEALTH CONDITION AFTER THIS PROCEDURE.

  Patient problems: Arthralgia; Failure of Implant; Fall; Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 17299298 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY WAS PERFORMED, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JOURNEY ARTICULAR INSERT BCS STANDARD 5-6 LEFT 9MM WAS EXPLANTED AND THE PATELLA WAS RESURFACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13996102 ↗
• InjurySep 14, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, ONE JOURN ART INS BCS STD 5-6 LT 9 BROKE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471662 ↗
• InjuryMay 18, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2009, A JOURN ART INS BCS STD 5-6 LT 9 WAS BROKEN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON AN UNKNOWN DATE. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11842112 ↗
• InjuryDec 2, 2020Break; Break

  GT HOLD 12 2 20IT WAS REPORTED THAT SURGEON CONTACTED REPRESENTATIVE ON (B)(6) 2020 TELLING THAT PATIENT HAD FALLEN AND THAT THE LEFT TOTAL REPLACEMENT IS NOW UNSTABLE. A REVISION SURGERY WAS BOOKED FOR THE REMOVAL OF BROKEN INSERT AND THE INSERTION OF THE NEW ARTICULATE INSERT FOR (B)(6) 2020.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931469 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT A POP BENDING OVER AND WAS SEEN IN THE ER FOR WHAT WAS BELIEVED TO BE A DISLOCATED KNEE OR POSSIBLE INSERT POST-FRACTURE. THE PATIENT WAS TAKEN TO SURGERY 2 DAYS LATER FOR AN INSERT EXCHANGE. THE INSERT POST WAS INTACT, BUT A THICKER INSERT WAS PLACED TO IMPROVE STABILITY. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10358076 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INSTABILITY. AT FIRST IT WAS THOUGHT THAT THE PEG WAS BROKEN BUT WHEN OPENING THE KNEE AND PERFORMING FURTHER INSPECTION, SURGEON DETERMINED THAT PATIENT HAD DEVELOPED OSTEOPOROSIS AND THE FEMORAL BONE COLLAPSED AS A RESULT. THIS CAUSED THE PAIN AND INSTABILITY. PROSTHESIS WAS REMOVED AND A LEGION REVISION WAS ON HAND TO COMPLETE IN 1 STAGE.

  Patient problems: Pain

  MAUDE report 9187417 ↗
• InjuryJun 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A DAMAGED JOURNEY 1 INSERT WAS REMOVED FROM THE PATIENT AND THAT THE POST WAS DISASSOCIATED FROM THE MAIN BODY OF THE INSERT RESULTING IN INSTABILITY. JOURNEY REVISION INSERT WAS IMPLANTED AND STABILITY WAS RESTORED.

  Patient problems: Injury

  MAUDE report 8702581 ↗
• InjuryApr 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN INSERT.

  Patient problems: Injury

  MAUDE report 8520420 ↗
• InjuryFeb 11, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE INSERT BROKE.

  Patient problems: Injury

  MAUDE report 8329135 ↗
• InjuryMay 13, 2018Break; Break

  IT WAS REPORTED THAT A CASE WAS BOOKED AS A LEFT JOURNEY INSERT EXCHANGE. ON DISCUSSION WITH THE SURGEON PRIOR TO THE START OF THE SURGERY, HE INDICATED THAT THE PATIENT HAD PREVIOUSLY HAD A KNEE ARTHROSCOPY OF THE SAME KNEE AND THE POST OF THE POLYETHYLENE HAD BROKEN OFF AND BEEN REMOVED. DURING THE INSERT EXCHANGE SURGERY THE SURGEON REMOVED THE POLYETHYLENE (SZ 5-6 9MM) USING A BRISTOW AND MALLET. HE PROCEEDED TO REMOVED ANY TISSUE THAT MAY INHIBIT THE INSERTION OF THE NEW POLYETHYLENE AND TRIALLED WITH AN INSERT 2MM THICKER THAN THE ORIGINAL SIZE.

  Patient problems: Injury

  MAUDE report 7509699 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PIN BROKE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7280880 ↗
• InjuryNov 24, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. THE JOURNEY INSERT WAS FOUND BROKE.

  Patient problems: Failure of Implant

  MAUDE report 7057939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, 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-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
• 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