LEGION 71424023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010546630), received between Apr 25, 2022 and Apr 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKR SURGERY IN 2019, PLAINTIFF CONTINUED TO EXPERIENCE SIGNIFICANT AND EXCRUCIATING PAIN IN THE RIGHT KNEE. PLAINTIFF WAS DIAGNOSED WITH A METAL ALLERGY TO COBALT, CHROMIUM, AND NICKEL. PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE IMPLANTS WITH ONES THAT DID NOT CONTAIN METALS. (CASE-(B)(4)) DURING REVISION SURGERY, ONCE THE SURGEON CEMENTED THE REPLACEMENT IMPLANTS IT WAS KNOWN THAT THE NEW IMPLANTS ALSO CONTAINED COBALT AND CHROMIUM THEREFORE THE SURGEON HAD TO CHISEL AWAY THE CEMENT AND REMOVE THE NEW IMPLANTS (CASE-(B)(4)) THIS SECOND PROCEDURE RESULTED IN BONE FRACTURE IN THE RIGHT LEG, CAUSING PAIN AND SEVERE POST-SURGICAL DISCOMFORT. PLAINTIFF HAS HAD TO UNDERGO ADDITIONAL REHABILITATION TREATMENT AND SUFFERS FROM PERMANENT INSTABILITY AND RESTRICTED MOBILITY.

  Patient problems: Bone Fracture(s); Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 14192079 ↗

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