LEGION 71453254Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556255834), received between Sep 30, 2018 and Jul 7, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST ON THE POLY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN XLPE PS INSERT SZ 5-6 13MM WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 22413090 ↗
• InjuryDec 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, 11 YEARS POSTOP TKA, THE POST OF A LGN XLPE PS INSERT SZ 5-6 13MM BROKE OFF INSIDE THE PATIENT AND REQUIRED A REVISION SURGERY ON (B)(6) 2024. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20995819 ↗
• MalfunctionAug 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SURGEON ATTEMPTED 4 TIMES TO PUT THE LEGION XLPE PS INSERT SIZE 5-6 13MM IN BUT IT DID NOT SEAT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A MINIMAL SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10432924 ↗
• InjurySep 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PATIENT NEEDED TO GET THE RIGHT TK DONE AND SO AT THE SAME TIME HE HAS REQUESTED THAT WE INCREASE THE THICKNESS OF HIS INSERT SO WE CAN IMPROVE THE STABILITY OF HIS LEFT KNEE. EXCHANGED THE INSERT FOR A 15 MM CONSTRAINED STABILIZED INSERT FOR LEFT KNEE.

  Patient problems: Injury; Joint Disorder

  MAUDE report 7921370 ↗

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-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-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