JOURNEY II XR 74023723Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556613047), received between Feb 18, 2019 and Aug 12, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THERE WAS A DISLOCATION. IT IS BELIEVED THAT THE BASEPLATE HAD BEEN SET WITH WRONG DEGREE. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE JOURNEY II XR INS XLPE MED 1-2 LT 11MM INSERT WAS EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10399877 ↗
• InjuryAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THERE WAS A DISLOCATION. IT IS BELIEVED THAT THE BASEPLATE HAD BEEN SET WITH WRONG DEGREE. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE JOURNEY II XR BASEPLATE SZ 2 LT WAS EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10399876 ↗
• InjuryFeb 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND LIMITED RANGE OF MOTION. BOTH SIDE INSERTS WERE REPLACED.

  Patient problems: Pain

  MAUDE report 8348308 ↗

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