JOURNEY 74022212Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010554376), received between Nov 30, 2017 and Oct 7, 2021 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2021Adverse 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) 2016, THE CLINICAL SUBJECT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. HOWEVER, IT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12595335 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A TKA REVISION SURGERY WAS PERFORMED FOR SUSPECTED TUMOR, IN ADDITION IT WAS FOUND DURING SURGERY THAT THE INSERT, THE BASE PLATE AND THE FEMORAL COMPONENT HAD SEVERE DAMAGE AND METALLOSIS. THE PRIMARY TKA WAS PERFORMED 4 YEARS EARLIER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology; Solid Tumor

  MAUDE report 12164293 ↗
• MalfunctionJun 22, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A TKA, THE JOURNEY II BCS XLPE ART ISRT SIZE 1-2 RIGHT 12MM ((B)(4)) AND COULD NOT BE FULLY SEATED TO JOURNEY TIBIA BASE NP RT SZ 2 ((B)(4)). THERE WAS A 15 MINUTE DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046606 ↗
• InjuryOct 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED AFTER THE SURGERY, IT WAS FOUND BY X-RAY THAT THE INCORRECT SIZING OF TIBIAL BASE PLATE WAS IMPLANTED. BEFORE SURGERY THE DOCTOR DECIDED THAT THE SIZE #1 HAD BEEN PLANNED TO BE IMPLANTED, BUT THE BIGGER SIZE #2 WAS OPENED AND IMPLANTED ACTUALLY. THIS IS THE USER ACCIDENT. SO THE DOCTOR DOES NOT BLAME THE PRODUCT. THERE IS NO HEALTH HARM TO PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10652443 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT SUFFERED FROM FAILURE TO PROGRESS WITH FLEXION. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA AND WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10538550 ↗
• InjuryAug 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER THE PROCEDURE TKA, THE PATIENT PRESENTED A LEFT KNEE STIFFNESS. THE PATIENT WAS TREATED UNDER ANESTHESIA. NOT MORE INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: Inflammation; Injury

  MAUDE report 10367101 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ORTHOPEDIC SURGERY HAD TO BE PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE. REHABILITATION THERAPY FOLLOWING THE TKA WITH JOURNEY II CR TKS WAS PERFORMED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 10154352 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS OF THE RIGHT KNEE. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842181 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEBRIDEMENT SURGERY DUE TO WOUND DEHISCENCE OF DISTAL RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8892480 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT KNEE PAIN AND STIFFNESS AND IT WAS RESOLVED WITH A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8845183 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8727654 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE BECAUSE IT TAKES LONG TIME AFTER IMPLANTATION. THE PRODUCTS CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7564070 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT RECEIVED KENALOG INJECTION/MEDROX DUE TO PES ANSERINUS TENDONITIS/ BURSITIS RIGHT KNEE.

  Patient problems: Inflammation

  MAUDE report 7072943 ↗

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