LEGION 71934165Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556143278), received between Jul 9, 2025 and Jul 9, 2025 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K230653, K933958); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE TIBIAL COMPONENT HAD SUBSIDED ON THE LATERAL SIDE OF THE TIBIA. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN POR HA TIB BASE W/O HOLES SZ 6 LT, PRO METAPH TIB STEM 18MM AND LGN CR HIGH FLEX XLPE SZ 5-6 9MM WERE EXCHANGED USING A LEGION REVISION SYSTEM AND UPSIZING THE TIBIAL BASEPLATE, AS THE ORIGINAL WAS UNDERSIZED WHICH CAUSE THE LATERAL SUBSIDENCE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22465362 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230653, K933958. 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