LEGION 71453258Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556255797), received between Feb 11, 2022 and Jan 2, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 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.

• InjuryJan 2, 2026Fracture; Material Fragmentation

  IT WAS REPORTED THAT AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT´S POST ON THE PS INSERT, BROKE OFF. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN XLPE PS INSERT SZ 7-8 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23950336 ↗
• InjurySep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED THE BREAKAGE OF THE INSERT POST. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LGN XLPE PS INSERT SZ 7-8 11MM WAS REVISED TO PSHF POLY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22963289 ↗
• InjuryAug 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, ONE (1) LGN XLPE PS INSERT SZ 7-8 11MM HAD A BROKEN POST. THIS EVENT WAS TREATED WITH A REVISION SURGERY ON THE (B)(6) 2025 IN WHICH THE INSERT WAS EXCHANGED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22840345 ↗
• InjuryAug 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED PAIN AND SHIFTING WHEN THE KNEE WAS FLEXED. IT WAS DETERMINED THAT THE POST OF THE LGN XLPE PS INSERT SZ 7-8 11MM FRACTURED. IN ORDER TO TREAT THIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A LGN XLPE PS INSERT SZ 7-8 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Joint Laxity; Pain

  MAUDE report 17561442 ↗
• InjuryJul 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2012, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE LGN XLPE PS INSERT SZ 7-8 11MM DUE TO THE POST SHEARING OFF. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911797 ↗
• InjuryJun 11, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKA A A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO A LGN XLPE PS INSERT SZ 7-8 11MM BROKE INSIDE THE PATIENT. ALL THE PIECES WERE REMOVED PRIOR TO IMPLANTING A NEW POLY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670162 ↗
• InjuryFeb 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2013, WHEN ARISING FROM A GROUND POSITION, THE PATIENT'S KNEE WOULD NOT STRAIGHTEN AND IT POPPED. THAT CAUSED PAIN IN THE LATERAL KNEE, IT BECAME SWOLLEN AND WOBBLY. IT WAS DETERMINED THAT THE LEGION HIGHLY CROSS LINKED POLYETHYLENE POSTERIOR STABILIZED INSERT SIZE 7-8 11MM BROKE OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE PIECES. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant; Joint Dislocation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 13515632 ↗

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