JOURNEY 71422255Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010582164), received between Jun 19, 2018 and Feb 10, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Difficult to Insert

  IT WAS REPORTED THAT, DURING A UKR SURGERY, A JOURNEY UNI TIBINRT S3-4RM/LL8MM WAS NOT GETTING LOCKED PROPERLY. THE SURGEON TRIED ANOTHER JOURNEY UNI TIBINRT S3-4RM/LL9MM, HOWEVER, IT ALSO FAILED TO LOCK AT THE FINAL STAGE. DUE TO THIS ISSUE, THE SURGEON HAD NO OPTION BUT TO REMOVE BOTH THE FEMORAL AND TIBIAL COMPONENTS, AND THE PROCEDURE WAS CONVERTED TO A TOTAL KNEE REPLACEMENT (TKR) INSTEAD OF THE PLANNED UNICONDYLAR KNEE REPLACEMENT (UKR). PROCEDURE WAS PERFORMED AFTER A GREATER THAN 30 MIN DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT'S CURRENT STATE OF HEALTH IS FINE.

  Patient problems: Laceration(s)

  MAUDE report 24310487 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT UKA SURGERY PERFORMED IN (B)(6) 2015, PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2015 TO EXPLANT THE LINER. PATIENT HEALTH STATUS IS NOT KNOWN. THIS INFORMATION WAS PROVIDED BY THE (B)(4), 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: Insufficient Information

  MAUDE report 15375122 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING UKR, THE JOURNEY UNI TIBINRT S3-4RM/LL8MM DID NOT LOCK INTO THE TIBIAL BASEPLATE AS EXPECTED. THE SURGEON TRIED FOR MANY ATTEMPTS BUT, THE DEVICE WAS NOT ABLE TO LOCK IT IN PLACE. A BACK-UP INSERT FROM SMITH AND NEPHEW WAS OPENED, AND IT LOCKED IN PLACE AT FIRST TRY. A SURGICAL 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 12082292 ↗
• MalfunctionApr 15, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A JOURNEY UNI UKA PROCEDURE TIBIAL INSERT FAILED TO LOCK INTO BASEPLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671388 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO PAIN, FEVER, SWELLING, MIGRATION AND LOOSENING OF TIBIAL BASE PLATE. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE. THIS WAS CAUSED BY HIGH WEIGHT OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Swelling; Pain

  MAUDE report 10259639 ↗
• InjuryOct 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF THE TIBIAL COMPONENT. ALL PARTS WERE REMOVED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9251632 ↗
• InjuryJun 19, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY REACHING FULL EXTENSION/FLEXION. AN INTERVENTION OF MANIPULATION UNDER ANESTHESIA WAS PERFORMED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7613815 ↗

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