JOURNEY II XR 74022293Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556615416), received between Jul 18, 2018 and Sep 24, 2021 — classified as 7 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 (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.

• InjurySep 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED LOOSENING OF LEFT TIBIAL COMPONENT WITH PROXIMAL TIBIAL PAIN ON (B)(6) 2020. THIS ISSUE IS STILL ONGOING. PATIENT HAS BEEN TREATED WITH A CONSERVATIVE TREATMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12527482 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRIMARY JOURNEY XR KNEE REPLACEMENT WAS DONE BY ANOTHER SURGEON IN (B)(6) 2020. THEN, THE PATIENT WAS REVISED ON (B)(6) BECAUSE THE PATIENT COMPLAINED OF KNEE PAIN AND COULD NOT FLEX THE KNEE PAST 95 DEGREES AFTER THE INITIAL OPERATION. THE SURGEONS IDENTIFIED THAT THE PROBLEM WAS BECAUSE THE JOINT LINE WAS RAISED BY ABOUT 10 MM AND THE TIBIAL SLOPE WAS DECREASED FROM ABOUT 10 DEGREES TO ZERO.

  Patient problems: Pain

  MAUDE report 11069521 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED BY IMPLANTING A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED DEEP SCAR FORMATION DUE TO A FALL. THE EVENT WAS TREATED VIA PROCEDURE: SYNOVECTOMY. THE SITUATION IS CONSIDERED RESOLVED.

  Patient problems: Injury

  MAUDE report 10082464 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT EXPERIENCED STIFFNESS OF THE RIGHT KNEE FOLLOWING SURGERY. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA. THE OUTCOME OF THE EVENT IS CONSIDERED UNKNOWN.

  Patient problems: Injury

  MAUDE report 9983322 ↗
• InjuryJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN WITH RANGE OF MOTION.

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 9566090 ↗
• InjuryJun 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER 6 WEEKS POST OP, PATIENT STILL DID NOT HAVE FULL FLEXION AND DECIDED TO PROCEED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 8676617 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS TO RELIEVE JOINT IMMOBILIZATION.

  Patient problems: Injury

  MAUDE report 7697387 ↗

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