JOURNEY 71422265Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010582249), received between Dec 27, 2017 and Nov 20, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AFTER A TKA SURGERY THAT WAS PERFORMED ON (B)(6) 2023, ONE (1) JOURNEY UNI TIBINRT S5-6RM/LL8MM HAD DISLOCATED. PATIENT WAS BROUGHT BACK TO THEATRE FOR A LINER EXCHANGE WHICH WAS COMPLETED SUCCESSFULLY. PATIENT RETURNED TO THEATRE AGAIN WITH ANOTHER POLY DISLOCATION SO WAS REVISED TO TKA ON (B)(6) 2023. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18171003 ↗
• InjuryNov 14, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AFTER A TKA SURGERY THAT WAS PERFORMED ON (B)(6) 2023, ONE (1) JOURNEY UNI TIBINRT S5-6RM/LL8MM HAD DISLOCATED. PATIENT WAS BROUGHT BACK TO THEATRE FOR A LINER EXCHANGE WHICH WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133619 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS A LATERAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON AN UNSPECIFIED DATE 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 16549730 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT 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) 2020 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 16545716 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2020 TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2020 DUE TO UNSPECIFIED COMPLICATIONS AND/OR ADVERSE EVENTS 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: Arthralgia; Insufficient Information; Pain

  MAUDE report 16542739 ↗
• InjurySep 6, 2022Degraded; Degraded

  IT WAS REPORTED THAT AFTER A RIGHT TKA PERFORMED ON (B)(6) 2015 DUE TO OSTEOARTHRITIS, THE INSERT WAS WEAR. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE ALL COMPONENTS WHERE EXCHANGE TO COMPETITOR´S IMPLANTS. THIS INFORMATION WAS PROVIDED BY 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: Failure of Implant; Insufficient Information

  MAUDE report 15360314 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2021 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED COMPONENT DISSOCIATION OF THE TIBIAL INSERT. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021 WERE THE JOURNEY UNI TIBINRT S5-6RM/LL8MM WAS EXPLANTED . THIS INFORMATION WAS PROVIDED BY 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: Joint Dislocation

  MAUDE report 15360292 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT AFTER A RIGHT THA PERFORMED ON (B)(6) 2016 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED DISLOCATION AND COMPONENT DISSOCIATION. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2017 AND THE JOURNEY UNI TIBINRT S5-6RM/LL8MM WAS 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 15358732 ↗
• InjuryJul 29, 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 WITH JOURNEY UNI ON (B)(6) 2020, THE PATIENT EXPERIENCED A PROGRESSIVE PATELLOFEMORAL ARTHRITIS. THIS EVENT WAS SOLVED BY A REVISION SURGERY, EXPLANTING THE JOURNEY UNI AND IMPLANTING THE GENESIS, ON (B)(6) 2021. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Arthritis

  MAUDE report 12250754 ↗
• InjuryApr 23, 2021Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A NAVIO ASSISTED UNICONDYLAR KNEE REPLACEMENT, THE PATIENT COLLAPSED INTO VALGUS. IMPLANTS WERE REVISED TO A LEGION HINGE WITH CONES AND STEMS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11720858 ↗
• InjuryMay 31, 2019Adverse 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 PATIENT HAD A KNEE REPLACEMENT ON (B)(6) 2018, WHERE HE HAD A BARING LOCKING MECHANISM FITTED. SHORTLY AFTER THE SURGERY THE BARING LOCKING MECHANISM FAILED CAUSING THE CLAIMANT TO SUFFER FROM SEVERE PAIN. THIS REQUIRED THE PATIENT TO UNDERGO A SECOND SURGERY ON (B)(6) 2018 WHICH FAILED AGAIN, AND A THIRD OPERATION WAS REQUIRED ON (B)(6) 2018. THE INSERT, TIBIAL AND FEMORAL COMPONENTS WERE REMOVED AND COMPETITOR DEVICES WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8660259 ↗
• InjuryDec 10, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ONE YEAR AFTER ORIGINAL SURGERY AND INSERT SHOWED DELAMINATION.

  Patient problems: Injury

  MAUDE report 8146232 ↗
• InjuryNov 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT MALFUNCTION. INSERT AND TIBIAL TRAY EXPLANTED. BACK UP AVAILABLE.

  Patient problems: Injury

  MAUDE report 8030427 ↗
• InjuryOct 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT MALFUNCTION. INSERT EXPLANTED. BACK UP AVAILABLE.

  Patient problems: Injury

  MAUDE report 8025856 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. SURGEON DOES NOT BLAME DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 7148142 ↗

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