JOURNEY 71422434Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4 · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556088296), received between Jun 19, 2018 and Oct 29, 2019 — classified as 4 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 (K102069, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Loose or Intermittent Connection1
- Mechanical Problem1
Patient problems
- Injury2
- Limited Mobility Of The Implanted Joint1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF THE TIBIAL COMPONENT. ALL PARTS WERE REMOVED. NO MORE INFORMATION IS AVAILABLE.
Patient problems: Injury
MAUDE report 9250734 ↗InjuryMay 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNEXPLAINED PAIN. NO MORE INFORMATION PROVIDED YET.
Patient problems: Pain
MAUDE report 8582460 ↗InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryJun 19, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY REACHING FULL EXTENSION/FLEXION. AN INTERVENTION OF MANIPULATION UNDER ANESTHESIA WAS PERFORMED.
Patient problems: Limited Mobility Of The Implanted Joint
MAUDE report 7614167 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K102069, K230653. One submission often covers many models, so check the product and lot details in each record.
- Z-2621-2023 · Aug 31, 2023 · Open, Classifiedsmith&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
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.