JOURNEY 71932912Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556058398), received between May 16, 2018 and Jun 26, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A FIFTH REVISION SURGERY OF THE LEFT KNEE DUE TO INSTABILITY AND EXTENSOR MECHANISM INSUFFICIENCY ON (B)(6) 2016. THE PROCEDURE COMPRISED THE REVISION SURGERY, A TOTAL PATELLECTOMY, AND RECONSTRUCTION OF CHRONIC EXTENSOR MECHANISM INSUFFICIENCY WITH CALCANEAL BONE BLOCK ACHILLES TENDON ALLOGRAFT WITH REPAIR OF QUADRICEPS AND PATELLAR TENDONS. DURING THE REVISION, THE INSERT WAS EXPLANTED AND REPLACED. AFTER THE PROCEDURE, THE PLAINTIFF KEPT HAVING THE IMPRESSION THAT HER KNEE WAS GETTING WORSE, HOWEVER, NO MORE INTERVENTIONS WERE PERFORMED. THE FOURTH REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, THE THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2015, THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 AND THE PRIMARY LEFT KNEE TKR SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 17197367 ↗
• InjuryMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH LEFT KNEE STIFFNESS. THE SUBJECT WAS HOSPITALIZED AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE WITH RESIDUAL EFFECTS.

  Patient problems: Injury

  MAUDE report 9901103 ↗
• 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 9711247 ↗
• 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 9485230 ↗
• 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 9484150 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INFECTION AND PAIN. NO ADDITIONAL DETAILS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8458291 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A DEBRIS-CONTAINING SYNOVITIS, LIKELY RELATED TO POLYMERIC WEAR OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8364637 ↗
• InjuryFeb 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DUE TO AN INFECTION A REVISION SURGERY WAS PERFORMED TO REMOVE FEMORAL COMPONENT, TIBIAL BASE, TIBIAL INSERT AND PATELLAR COMPONENT.

  Patient problems: Pain

  MAUDE report 8364626 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT SUFFERED FROM DERMATITIS SINCE TWO WEEKS AFTER THE KNEE REPLACEMENT ON BOTH LEGS. PATIENT IS WILLING TO OBTAIN A METAL ALLERGY TEST (MELISA TESTING) FROM A MEDICAL INSTITUTE IN (B)(6). PATIENT HAS RECEIVED MULTIPLE DUPIXENT INJECTIONS, ONCE EVERY TWO WEEKS SINCE (B)(6) 2017 FOR RASH AND ITCHING.

  Patient problems: Skin Irritation

  MAUDE report 7519026 ↗

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-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
• 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