JOURNEY II XR 74023830Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556615607), received between Jan 22, 2019 and Dec 23, 2020 — 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.

• 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 11069704 ↗
• 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 10082463 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A PRIMARY TKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED OCCASIONAL SWELLING AND PAIN. THE IMPLANTED TKR SYSTEM FAILED: IT IS BELIEVED THAT TIBIAL LOOSENING WAS IMPLICATED. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JOURNEY II LATERAL INSERT. AN S&N LEGION SYSTEM WAS IMPLANTED INSTEAD. THE EVENT IS CONSIDERED AS RESOLVED.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 10027432 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED PES ANSERINUS WHICH WAS TREATED USING REPEAT DEPO MEDROL STEROID INJECTIONS.

  Patient problems: Injury

  MAUDE report 8683723 ↗
• InjuryJun 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LIMITED RANGE OF MOTION DURING 6 WEEKS POST OP VISIT, AND IT PROCEEDED WITH MANIPULATION UNDER ANESTHESIA. POST OP VISIT AFTER MUA, THE PATIENT WAS GIVEN DYNASPLINT TO IMPROVE EXTENSION. 6 WEEKS POST MUA PATIENT'S RANGE OF MOTION WAS SIGNIFICANTLY IMPROVED.

  Patient problems: Injury

  MAUDE report 8683710 ↗
• InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND PAIN A MONTH AFTER THE PRIMARY SURGERY. A MANIPULATION UNDER "ANESTESIA" WAS PERFORMED AND AN ASPIRATION AND A MARCAINE INJECTION WERE GIVEN TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8279390 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT REQUIRED A REVISION SURGERY BECAUSE OF PAIN AND DISCOMFORT.

  Patient problems: Pain

  MAUDE report 8269169 ↗

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