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JOURNEY II 71935201Recalls & reported problems

Smith & Nephew, Inc. · JII UNI TIB BASE SZ 3 RM/LL · Class 2 · Implant

All models of JOURNEY II (22)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556578803), received between Dec 3, 2021 and Dec 12, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152315, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • Failure of Implant1
  • Inadequate Osseointegration1
  • Pain1

Recent adverse event reports

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

  • InjuryDec 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT, AFTER A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. A REVISION SURGERY WAS PERFORMED ON AN UNSPECIFIED DATE TO TREAT THIS ADVERSE COMPLICATION. DURING THIS PROCEDURE, ALL COMPONENTS WERE REVISED AS THE KNEE WAS CONVERTED TO A TKA. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED SEVEN (7) MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 15965511 ↗
  • InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020. THE CAUSE OF THE REVISION SURGERY IS UNSPECIFIED. THE PATIENT HAS RECOVERED FROM REVISION SURGERY.

    Patient problems: Failure of Implant; Pain

    MAUDE report 12924266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152315, 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

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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