LEGION 71421752Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010545183), received between Jan 10, 2019 and Dec 6, 2019 — classified as 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K041106, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A REVISION SURGERY, WITH THE SURGEON'S APPROVAL, AN EXPIRED WEDGE WAS IMPLANTED. THE PACKAGING WAS PERFECT. THE SEAL AND PLASTIC LID WAS INTACT AND IN PERFECT CONDITION. SURGEON WAS FULLY AWARE THAT THE PRODUCT WAS EXPIRED AND WANTED TO MOVE FORWARD WITH THE PROCEDURE. NO DELAY. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9433406 ↗
• MalfunctionJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING REVISION AN EXPIRED DEVICE WAS IMPLANTED ON THE PATIENT. NO DELAY OR INJURY REPORTED. BACK UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041106, 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-0092-2018 · Sep 14, 2017 · Terminated
  smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid