LEGION 71421805Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010545398), received between Jun 19, 2020 and Oct 13, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LGN POS FEM WDG 5MM SZ5-6 LNG WOULD NOT TIGHTEN DOWN COMPLETELY EVEN WITH THE SCREW ALL THE WAY TIGHTENED. THIS RESULTED IN THE AUGMENT HAVING TO BE CEMENTED. THE PATIENT CONDITION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10673601 ↗
• InjuryOct 12, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LGN POS FEM WDG 5MM SZ5-6 LNG WOULDN¿T TIGHTEN DOWN COMPLETELY EVEN WITH THE SCREW ALL THE WAY TIGHTENED. THIS RESULTED IN THE AUGMENT HAVING TO BE CEMENTED. THE PATIENT¿S CONDITION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10667415 ↗
• MalfunctionJun 19, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY WHEN TRYING TO ASSEMBLE THE 5 MM POSTERIOR AUGMENT THE SCREW WOULD NOT ENGAGE AND LOCK DOWN THE AUGMENT. IT WAS TRIED FOR AT LEAST 20 MINUTES. A BACK UP DEVICE WAS USED AND IT WENT DOWN EASILY. IT WAS FOUND THAT THE THAT THE SCREW WAS DIFFERENT IN THE SECOND PACKAGE. IT WAS BOTH SMALLER IN WIDTH AND LENGTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173177 ↗

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