JOURNEY II XR 74022292Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556615409), received between Feb 21, 2019 and Feb 28, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K152726, 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 18, 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 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE JRNY II XR BASEPLATE SZ 2 RT WAS SEATED ON TIBIA, IT DID NOT FULLY FIT. THE SURGEON, ADDITIONALLY REMOVED BONE AT PEG AND KEEL, BUT THE PROBLEM WAS NOT RESOLVED. THEN, SURGEON REMOVED BONE CEMENT, RETRIED AND KEEL PUNCH BUT THE PROBLEM WAS NOT RESOLVED EITHER. FINALLY, SURGEON WIDENED THE HOLE IN THE BONE WITH A DRILL AND THE BASEPLATE COULD BE SEATED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Rupture

  MAUDE report 16455140 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE TKA SYSTEM WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED PROSTHESIS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14548268 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE, REVISION SURGERY WAS PERFORMED DUE TO THE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL BASEPLATE. THE DOCTOR SAYS THE S+N DEVICES WERE NOT DEFECTIVE. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10248554 ↗
• InjurySep 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGICAL PROCEDURE DUE TO STIFFNESS. THERE IS ONLY INFORMATION OF THE FEMORAL COMPONENT AND TIBIAL BASE COMPONENT BEING INVOLVED.

  Patient problems: Injury

  MAUDE report 9068744 ↗
• InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN. THE XR INSERTS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 8480366 ↗
• InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS DEEP VEIN THROMBOSIS ON THE RIGHT KNEE. THE ISSUE HAS BEEN RESOLVED WITH MEDICATION THERAPY.

  Patient problems: Swelling

  MAUDE report 8461732 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION AND ACL RUPTURE. ALL IMPLANTS WERE REPLACED.

  Patient problems: Rupture

  MAUDE report 8359188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152726, 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