LEGION 71424051Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010546821), received between Nov 3, 2018 and Mar 1, 2022 — classified as 5 injuries, 1 malfunction.

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 (K072531, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Contamination; Contamination

  IT WAS REPORTED THAT, A LGN PRESSFIT STEM 18MM X 160MM HAD A HAIR INSIDE THE STERILE PACKAGING. AS THIS WAS NOTICED DURING THE SET-UP OF AN TKA SURGERY, THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638834 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ONE MONTH AND A HALF AFTER A REVISION SURGERY, THE PATIENT EXPERIENCED AN ACS. THE PATIENT WAS DISCHARGED FROM HOSPITAL AFTER ABOUT 10 DAYS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED AND SO IS THE CURRENT STATUS.

  Patient problems: Bacterial Infection; Ischemic Heart Disease; Pyogenic Infection

  MAUDE report 10681313 ↗
• InjuryJun 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD REPLACEMENT SURGERY ON (B)(6) OF 2020. THE UNIT OF LEGION RK REVISION KNEE MAKES EXCESSIVE NOISE (GRINDING/POPPING) WHEN WALKING. THE PATIENT ALSO HAS CONTINUOUS PAIN/STIFFNESS ON THE LEFT SIDE OF THE KNEE SINCE THE REPLACEMENT SURGERY. THE PATIENT HAS BEEN ATTENDING PHYSICAL THERAPY 3 TIMES PER WEEK AND TREATING THE PAIN WITH MEDICATION. THERE ARE NO MEDICAL INTERVENTIONS DONE DUE TO THIS ISSUE.

  Patient problems: Injury

  MAUDE report 10145543 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT LOOSENING. HINGE STRESS CAUSED THE FIXATION IMPLANTS TO BE LOOSE. PRIMARY SURGERY PERFORMED ON (B)(6) 2015.

  Patient problems: Injury

  MAUDE report 9770314 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION WHICH INCLUDES REMOVING ALL IMPLANTS AND INSERTING AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8046279 ↗
• InjuryNov 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD OCCASIONAL CLICKING AND POPPING WHILE WALKING. DOCTOR SUGGESTED A CONSTRAINED KNEE REVISION AND SYNOVECTOMY SINCE IMPLANTS APPEAR TO BE WELL FIXED AND ALIGNED BUT THERE ARE SOME SUBTLE RADIOLUCENCIES AROUND CEMENTLESS STEMS. A CONSTRAINED POLYETHYLENE AVAILABLE WAS REQUESTED BY THE DOCTOR FOR THE REVISION SURGERY AND POTENTIALLY REVISION IMPLANTS, ALTHOUGH UNLIKELY TO BE NEEDED. INFORMATION ABOUT REVISION SURGERY HASN'T BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8036269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072531, 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