LEGION 71453277Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556255704), received between May 14, 2018 and Mar 26, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A BILATERAL TKR SURGERY, ONE (1) LGN XLPE DISHED ISRT SZ 3-4 9MM DID NOT GET LOCK AT THE TIME OF FINAL IMPLANTATION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706980 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A POLY EXCHANGE ON (B)(6) 2025 AFTER A SYNOVECTOMY. DURING THIS REVISION SURGERY, A LEGION HIGHLY CROSS LINKED POLYETHYLENE DISHED INSERT SIZE 3-4 9MM WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Synovitis

  MAUDE report 21692068 ↗
• MalfunctionOct 13, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR A TKA, WHEN OPENING THE INNER PACKAGE OF A LGN XLPE DISHED ISRT SZ 3-4 9MM THE WAS A PUNCTURE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436168 ↗
• MalfunctionNov 23, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE LEGION XLPE DISHED INSERT SIZE 3-4 9MM WOULD NOT LOCK IN TO THE BASEPLATE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883792 ↗
• MalfunctionNov 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE LGN XLPE DISHED ISRT SZ 3-4 9MM WOULD NOT LOCK INTO TIBIAL BASE PLATE. THERE WAS NO DELAY AND PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10855471 ↗
• InjuryMay 14, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO KNEE INSTABILITY.

  Patient problems: No Information

  MAUDE report 7511023 ↗

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-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
• 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