JOURNEY II XR 74024025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556616536), received between Apr 14, 2020 and Aug 3, 2020 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TKR ON (B)(6) 2018. DESPITE PHYSICAL THERAPY AND ADEQUATE PAIN MANAGEMENT, THE PATIENT WAS UNABLE TO MAINTAIN AN ACCEPTABLE POST-OP KNEE RANGE OF MOTION (KNEE STIFFNESS). MANIPULATION UNDER ANESTHESIA WAS PERFORMED TWICE. ACTIONS TAKEN WERE: SURGERY, MEDICATION THERAPY AND PHYSICAL THERAPY. THE PATIENT GAINED SIGNIFICANT ROM & WAS ABLE TO ACHIEVE MORE TERMINAL FLEXION. THE OUTCOME OF THIS EVENT IS STILL ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10356734 ↗
• InjuryApr 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER PRIMARY SURGERY, USING JOURNEY II XR IMPLANTS PATIENT HAD KNEE STIFFNESS AND DECREASED RANGE OF MOTION. DESPITE PHYSICAL THERAPY; ADEQUATE PAIN MANAGEMENT, THE PATIENT WAS UNABLE TO MAINTAIN AN ACCEPTABLE POST OPERATIVE KNEE RANGE OF MOTION. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. PATIENT GAINED SIGNIFICANT RANGE OF MOTION AND WAS ABLE TO ACHIEVE MORE TERMINAL FLEXION.

  Patient problems: Loss of Range of Motion

  MAUDE report 9957529 ↗

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