LEGION 71424055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010546845), received between Nov 3, 2018 and Nov 3, 2018 — classified as 1 injury.

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 (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.

• 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 8036267 ↗

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