JOURNEY II XR 74022208Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556615386), received between Aug 22, 2018 and Jun 23, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT HEARTBURN/CHEST PAIN FOR WEEKS PRIOR TO HOSPITALIZATION, HE BELIEVED THIS WAS DUE TO GERD. HE WAS THEN ADMITTED TO THE HOSPITAL AND REQUIRED STENT AND BYPASS AFTER CARDIAC TESTING.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 8725627 ↗
• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER 8 WEEKS POST-OP, THE PATIENT STILL HAD LIMITED RANGE OF MOTION AFTER AGGRESSIVE PHYSICAL THERAPY, FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED DUE TO THE STIFFNESS.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8725620 ↗
• InjuryAug 22, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON CHOSE TO REMOVE THE IMPLANTED XR AND REVISE TO A BCS.

  Patient problems: No Code Available

  MAUDE report 7805005 ↗

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