JOURNEY 71422251Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010582126), received between Dec 18, 2018 and Dec 30, 2024 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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.

• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN DUE TO A WORN JOURNEY UNI TIBINRT S3-4LM/RL8MM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY OF UNI TKR TO PRIMARY TKA ON (B)(6) 2024, IN WHICH JUNI OX FB FEM SZ 5 LM RL, JOURNEY UNI TIBINRT S3-4LM/RL8MM AND JRNY UNI TIBIAL BASE LM/RL SZ 4 WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 21036215 ↗
• InjurySep 12, 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) 2019 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 15399836 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A LEFT TKA PERFORMED ON (B)(6) 2020 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED A ASEPTIC LOOSENING OF THE TIBIAL IMPLANT AND COMPONENT DISSOCIATION OF THE INSERT. 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 (B)(6), 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: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 15360166 ↗
• InjurySep 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  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) 2018 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: Arthritis; Joint Dislocation

  MAUDE report 15354113 ↗
• InjuryJun 4, 2022Adverse 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) 2022, PATIENT DISLOCATED THE JOURNEY UNI TIBINRT S3-4LM/RL8MM. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE POLY. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 14599408 ↗
• InjuryMay 31, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, PATIENT DISLOCATED THE JOURNEY UNI TIBINRT S3-4LM/RL8MM. THE ADVERSE EVENT WAS ADDRESSED WITH A SECOND REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE POLY. THE FIRST REVISION SURGERY WAS PERFORMED DUE TO THE SAME REASON ON (B)(6) 2022. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14545576 ↗
• InjuryMay 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2013, THE JOURNEY UNI TIBINRT S3-4LM/RL8MM DISLOCATED AT SOME POINT IN THE LAST MONTH. A REVISION SURGERY WAS PERFORMED ON (B)(6)2022 TO SOLVED THIS ADVERSE EVENT. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14412103 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE TIBIAL BASEPLATE BECAME LOSE, THE CEMENT WAS STILL ATTACHED TO THE TIBIAL IMPLANT BUT CEMENT FAILED (LOOSENED FROM TIBIAL BONE), IT WAS NOT A S&N CEMENT. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2021, IN WHICH THE ORIGINAL UNI IMPLANTS WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12908628 ↗
• InjuryMay 18, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A UKR, THE JOURNEY UNI TIBINRT S3-4LM/RL8MM WAS WRONGLY PACKED CAUSING IT TO BE USED TO IMPLANTATION WITH A JOURNEY II TIBIAL BASE. SURGEON SPENT 10-15 MIN TRYING TO PUT IT IN, UNTIL REALIZED IT WAS A JOURNEY I INSERT. NO BACK-UP DEVICE WAS AVAILABLE, SO A JOURNEY II UNI TIB XLPE INS SZ 3-4 9MM LM/RL WAS IMPLANTED. A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842586 ↗
• MalfunctionJul 7, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY, THE INSERT WAS NOT LOCKED WELL. AT THE ANTERIOR OF THE DEVICE, IT WAS CONFIRMED THERE WAS A GAP. THE BACK-UP DEVICE WAS UTILIZED. THIS EVENT CAUSED 5 MINUTES DELAY OF SURGERY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242134 ↗
• MalfunctionDec 17, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY WHEN IMPLANTING THE INSERT, THE INSERT COULD BE EASILY PLACED IN THE TIBIAL BASEPLATE SLOT BARE-HANDED (WITHOUT THE IMPACTOR). ALSO, TESTING WITH BENT PLIERS, THE INSERT COULD BE EASILY TAKEN OUT OF THE SLOT. ANOTHER INSERT OF THE SAME CODE WAS USED, BUT THE RESULT WAS THE SAME, AND IT WAS STILL LEFT INSIDE THE PATIENT. SINCE THERE WAS NO REVISION INSTRUMENT AT THAT TIME AND THE SURGEON COULD NOT GUARANTEE THE REVISION RESULT, THE SUTURE WOUND TREATMENT WAS SELECTED AT THAT TIME AND THE LONG-TERM POSTOPERATIVE SITUATION OF THE PATIENT WAS UNCERTAIN. THERE WAS A DELAY OF 0-30 MINUTES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9478623 ↗
• InjurySep 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A DEUCE WAS IMPLANTED IN 2008. IN SURGERY FOUND FX TIBIAL TRAY IN 2 PIECES. POLY, FEMORAL AND TIBIAL COMPONENT WERE COMPLETELY REMOVED AND PRIMARY LEGION KNEE WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8991778 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SLOW POST-OP RECOVERY DUE TO PAIN.

  Patient problems: Injury

  MAUDE report 8176621 ↗

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