JOURNEY 71422364Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010627476), received between Aug 10, 2021 and Mar 15, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K073175, K081351, 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 4 most recent of 4 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 RIGHT LATERAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS A LATERAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY, SCAR REMOVAL, AND PATELLA CARTILAGE SMOOTHING ON AN UNKNOWN DATE DUE TO UNSPECIFIED COMPLICATIONS AND/OR ADVERSE EVENTS. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED TWO HUNDRED SIXTEEN (216) DAYS FOLLOWING THE INDEX IMPLANTATION. 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: Insufficient Information

  MAUDE report 16545986 ↗
• InjuryMar 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON AN UNKNOWN DATE DUE TO THE LOOSENING OF THE IMPLANTS. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED EIGHTY-ONE (81) DAYS FOLLOWING THE INDEX IMPLANTATION. 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: Inadequate Osseointegration

  MAUDE report 16545868 ↗
• InjuryMar 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6) 2021 TO ADDRESS A MEDIAL GONARTHROSIS SYMPTOMS, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2021 DUE TO THE LOOSENING OF THE IMPLANTS, THE CEMENT USED BROKE. 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; Inadequate Osseointegration

  MAUDE report 16545782 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED PAIN FOLLOWING THE SURGERY, THE EVENT WAS TREATED VIA MEDICATION. ON (B)(6) 2021 SUBJECT HAD A REVISION SURGERY. SUBJECT OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12302347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073175, K081351, 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