JOURNEY 71422426Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556088098), received between Aug 24, 2018 and Sep 7, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K102069, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A LEFT UKA SURGERY PERFORMED IN (B)(6) 2014, PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2016 TO EXPLANT THE FEMORAL AND TIBIAL COMPONENTS, AND THE 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: Inadequate Osseointegration

  MAUDE report 15375257 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS A POSTOPERATIVE INFECTION. THE CUSTOMER WANTS TO CHECK THE STERILITY OF THE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 8493803 ↗
• InjuryApr 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A POSTOPERATIVE INFECTION. THE CUSTOMER ASKS IS TO CHECK THE LOT REGARDING STERILITY.

  Patient problems: Unspecified Infection

  MAUDE report 8490069 ↗
• InjuryDec 12, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFENING IN THE PATIENT'S LEFT KNEE RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8156157 ↗
• InjuryAug 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED SINCE PATIENT FELL IN (B)(6). PATIENT WENT TO THE DOCTOR FOUR WEEKS LATER IN (B)(6) AND DOCTOR THOUGHT THE POLY WAS DISENGAGED. HE WAS GOING TO DO A POLY SWAP BUT WHEN HE OPENED THE KNEE, THERE WAS A HUGE GASH IN THE FEMUR AND BLACK TISSUE ALL AROUND THE KNEE.

  Patient problems: Injury

  MAUDE report 7814437 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102069, 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