JOURNEY 74021257Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556615195), received between Apr 27, 2018 and Mar 27, 2023 — classified as 5 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K121443, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A VISIONAIRE ASSISTED RIGHT TKR WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED ISSUES WITH SCAR TISSUE GROWTH, PAIN, AND SWELLING WHICH SEEMS TO BE LIMITING HIS RANGE OF MOTION. ON (B)(6) 2022, A KNEE MANIPULATION WAS PERFORMED WHICH REDUCED THE KNEE RANGE OF MOTION EVEN MORE. OVER THE LAST 9 MONTHS WITH ORTHOEPIC MASSAGE AND PHYSICAL THERAPY PATIENT CAN EXTEND HIS LEG TO 10 DEG AND FLEX IT TO 110 DEG, WITH POPPING. THE PATIENT KEPT SUFFERING FROM PERSISTENT STIFFNESS. ON (B)(6) 2023, THE MAIN SYMPTOMS WERE LOSS OF EXTENSION AND ABNORMAL GAIT. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY WITH LYSIS OF ADHESIONS AND A MANIPULATION UNDER ANESTHESIA. THE PATIENT IS MAKING PROGRESS, BUT IT¿S STILL VERY SLOW AND LIMITED. ON 25-JUL-2023 THE PATIENT INDICATED THAT OVER THE LAST THREE (3) MONTHS THERE HAVE NOT BEEN ANY MORE IMPROVEMENTS.

  Patient problems: Fibrosis; Loss of Range of Motion; Scar Tissue; Swelling/ Edema

  MAUDE report 16620738 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORI-ASSISTED TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT DEVELOPED ARTHROFIBROSIS IN THE RIGHT KNEE (SYMPTOM ONSET: (B)(6) 2021).THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. ON THE (B)(6) 2021 THE PATIENT WAS APPOINTED AS RECOVERED.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 12171164 ↗
• InjuryMay 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT PRESENTED DEEP VEIN THROMBOSIS (DVT) IN LEFT LEG. THIS ADVERSE EVENT HAS BEEN TREATED WITH MEDICATION IS NOW RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11885726 ↗
• InjuryJul 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A RIGHT KNEE EFFUSION.

  Patient problems: Injury

  MAUDE report 7716326 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED RIGHT KNEE ARTHROFIBROSIS. A MANIPULATION UNDER ANESTHESIA WAS DONE.

  Patient problems: Injury

  MAUDE report 7470886 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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