Legion 71935387Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556645390), received between Sep 24, 2018 and May 9, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K162775, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY THE CONSTRUCTED IMPLANTS WOULD NOT FIT PROPERLY IN PATIENT. MORE THAN 30 MINUTES OF DELAY WAS REPORTED AND BACKUP DEVICE WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597361 ↗
• InjuryApr 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND ALL PARTS WERE REMOVED. PATIENT RECEIVED ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8497835 ↗
• InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFNESS OF STUDY KNEE. NO SURGERY REQUIRED AND NO COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 7900971 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162775, 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
• Z-2624-2017 · May 30, 2017 · Terminated
  LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
• Z-2625-2017 · May 30, 2017 · Terminated
  LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM