LEGION 71453278Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556255698), received between Jun 15, 2017 and Nov 11, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT STARTED TO HAVE AN ONGOING PAIN AND SLIGHT LIGAMENT LAXITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO REPLACE THE LGN XLPE DISHED ISRT SZ 3-4 11M. THE PATIENT WAS DISCHARGED AND IS CURRENTLY RECOVERING WELL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20650453 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A TKA ON (B)(6) 2023, PATIENT REQUIRED LGN XLPE DISHED ISRT SZ 3-4 11M EXCHANGE DUE TO SOFT TISSUE LAXITY. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, IN WHICH SURGEON NEEDED TO UPSIZE THE POLY THICKNESS TO GAIN STABILITY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 19721171 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF A PAINFUL KNEE. CLINICALLY SHE WAS SLIGHTLY UNSTABLE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. SURGEON REMOVED A SZ 3-4, 11MM LEGION PRIMARY DISHED INSERT AND IMPLANTED A SZ 3-4, 13MM DISHED INSERT AND PATIENT INSTABILITY WAS MUCH BETTER. SURGEON ELECTED NOT TO REMOVE THE FEMUR AND PROCEED WITH A PS OR REVISION STYLE FEMUR AND INSERT. CURRENT HEALTH STATUS OF PATIENT IS SATISFACTORY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18983899 ↗
• MalfunctionJan 28, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY THE LEGION XLPE DISHED INSERT SIZE 3-4 11M WOULD NOT CONNECT INTO THE TIBIA. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242912 ↗
• InjuryMay 6, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSTABLE TOTAL KNEE WITH SIGNIFICANT COLLATERAL INSTABILITY, CONSTRAINED FEMORAL IMPLANT AND CONSTRAINED INSERT. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 8582846 ↗
• InjuryMar 6, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  LEGION PRIMARY WITH VERILAST, STUDY ID: (B)(6); SUBJECT # (B)(6); AE#01: TKR LOOSENING SUSPICION. IT WAS REPORTED THAT A YEAR AFTER TKR IT IS SUSPECTED THAT PATIENT HAS LOOSE COMPONENTS AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8394832 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS REPORTED FOR PAIN. A POLY SWAP OCCURRED.

  Patient problems: Pain

  MAUDE report 6645048 ↗

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-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-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-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