JOURNEY II XR 74023730Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556613061), received between Jan 22, 2019 and Nov 5, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Degraded; Degraded

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, PATIENT EXPERIENCED SUBLUXATION OF THE JOURNEY XR TKA WITHOUT PREVIOUS TRAUMA. IN ADDITION, ON RADIOGRAPHY THERE IS A HIGH SUSPICION OF SEVERE PE WEAR OF THE JRNY II XR INS XLPE MED 3-4 RT 8MM. PATIENT WAS SEEN ON THE OUTPATIENT WARD ON (B)(6) 2025, WITH PROGRESSIVE COMPLAINTS OF PAIN OF THE RIGHT KNEE. A FULL REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE ADVERSE EVENT, DURING WHICH THE FEMORAL COMPONENT WAS NOTED TO BE DAMAGED WITH PRESENCE OF METALLOSIS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Bone Notching; Deformity/ Disfigurement; Joint effusion; Metal Related Pathology; Subluxation

  MAUDE report 23476443 ↗
• 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 10082459 ↗
• 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 MEDIAL INSERT. AN S&N LEGION SYSTEM WAS IMPLANTED INSTEAD. THE EVENT IS CONSIDERED AS RESOLVED.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 10027431 ↗
• InjuryJun 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT RIGHT KNEE STIFFNESS WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8746776 ↗
• 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 8683718 ↗
• 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 8683695 ↗
• 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 ANESTHESIA WAS PERFORMED AND AN ASPIRATION AND A MARCAINE INJECTION WERE GIVEN TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8279318 ↗
• 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 8269134 ↗

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