LEGION 71453281Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556255674), received between Apr 24, 2019 and Jun 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K071071, 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.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TKA PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A TIBIAL DISLOCATION WHILE ATTEMPTING TO MOVE HERSELF DOWN THE BED. DR. (B)(6) NOTED THAT THE POSTERIOR CAPSULE APPEARED TO REMAIN INTACT AND ATTRIBUTED THE DISLOCATION TO A LEVERING ACTION DURING SIMULTANEOUS KNEE FLEXION AND INTERNAL ROTATION. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2025. DURING THIS PROCEDURE, ONE (1) LEGION¿ CR OXIN FEM SZ3 LT AND ONE (1) LGN XLPE DISHED INSERT SZ 3-4 15MM WERE REMOVED. IT WAS DETERMINED THAT A POSTERIOR-STABILISED KNEE IMPLANT WOULD BE MORE APPROPRIATE TO PREVENT RECURRENCE. WHILE REMOVING THE WELL-CEMENTED FEMORAL COMPONENT, A SIGNIFICANT AMOUNT OF BONE REMAINED ATTACHED TO THE IMPLANT. AS A RESULT, A REVISION FEMORAL PROSTHESIS WITH A STEM AND AUGMENTS WAS USED TO COMPENSATE FOR THE BONE LOSS. THE POST ON THE POSTERIOR-STABILISED POLYETHYLENE INSERT SUCCESSFULLY PREVENTED FURTHER DISLOCATION, ALLOWING THE TIBIAL COMPONENT TO BE LEFT IN SITU. PATIENT IS RECOVERING WELL.

  Patient problems: Joint Dislocation; Laceration(s); Unspecified Tissue Injury

  MAUDE report 22184554 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT RIGHT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSE TIBIA.

  Patient problems: Injury

  MAUDE report 8546972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071071, 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-1507-2020 · Dec 19, 2019 · Terminated
  LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
• Z-1904-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and post
• Z-1905-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and post
• Z-1907-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and poster
• Z-1906-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and poste