JOURNEY 71422261Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010582201), received between Jul 26, 2018 and Mar 15, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K061011, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2019 TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2019 DUE TO AN UNSPECIFIED INFECTION WHERE THE TIBIAL INSERT WAS EXCHANGED. THE OUTCOME OF THIS PATIENT IS UNKNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED RETROSPECTIVELY; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16546288 ↗
• InjurySep 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2016, PATIENT EXPERIENCED A COMPONENT DISSOCIATION. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXPLANT THE FEMORAL, TIBIAL COMPONENTS, AND INSERT. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15375250 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED COMPONENT DISSOCIATION. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2020 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15360204 ↗
• InjurySep 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED COMPONENT DISSOCIATION OF THE INSERT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE ALL COMPONENTS WHERE EXCHANGE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A REVISION SURGERY OF JOURNEY UNI PROTHESIS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15354174 ↗
• InjuryApr 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, WITH A UNI JOURNEY SYSTEM, THE PATIENT EXPERIENCED PAIN. X-RAYS INDICATED THAT THE JOURNEY UNI TIBINRT S5-6LM/RL8MM WAS NOT IN ITS POSITION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JOURNEY UNI TIBINRT S5-6LM/RL8MM WAS REMOVED. THE PATIENT'S HEALTH STATUS IS STABLE.

  Patient problems: Implant Pain; Joint Dislocation; Pain

  MAUDE report 13996109 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THREE WEEKS AFTER A JOURNEY UNI TIBINRT S5-6LM/RL8MM UNI-COMPARTMENTAL KNEE REPLACEMENT, AN INFECTED WOUND WAS FOUND; THEREFORE, THE SURGEON DECIDED TO DEBRIDE AND REPLACE THE TIBIAL INSERT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 10427915 ↗
• InjuryAug 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING UNI-TKA SURGERY, THE JOURNEY UNI TIBIAL INSERT S5-6LM/RL8MM COULD NOT BE IMPLANTED. THE SURGEON MADE A CHANGE IN SURGICAL TECHNIQUE AND USED A BIGGER SIZE INSERT TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367102 ↗
• InjuryJul 1, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE JOURNEY UNI TIBIAL INSERT SZ 5-6 LM/RL 8MM LUXATED WHEN THE PATIENT WENT DOWN ON HIS KNEES. THE SURGEON ALWAYS FIXES THE INLAY TO THE TIBIAL PLATEAU BEFORE IMPLANTATION, IT WAS FIXED FIRMLY AND IT LUXATED UNDER LOAD. IT HAS BEEN COMMUNICATED THAT THE PATIENT IS A ROOFER AND REGULARLY PERFORMS KNEELING WORK. THE EXPLANTED INSERT IS IN PATIENT'S POSSESSION AND FURTHER INFORMATION WILL NOT BECOME AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217809 ↗
• InjuryDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TRANSLATION OF THE PLASTIC PROSTHESIS. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9450295 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO A POLY SWITCH OF AN ACUTE INFECTION 2 WEEKS POSTOPERATIVE.

  Patient problems: Unspecified Infection

  MAUDE report 8712937 ↗
• InjuryApr 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A POSTOPERATIVE INFECTION. THE CUSTOMER REQUIREMENT IS TO CHECK THE LOT REGARDING STERILITY. NO MORE INFORMATION PRESENTED.

  Patient problems: Unspecified Infection

  MAUDE report 8504461 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY ON LEFT KNEE WAS PERFORMED DUE TO PAIN AND SWELLING. PATIENT WAS TREATED WITH A JOINT INJECTION ON (B)(6) 2018. SINCE THE ISSUE WASN'T RESOLVED WITH THE INJECTION, DR DECIDED TO PERFORM A SURGICAL PROCEDURE ON (B)(6) 2018 TO REMOVE THE PARTS.

  Patient problems: Pain; Swelling

  MAUDE report 7724618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061011, 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