LEGION 71453203Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556034804), received between Sep 18, 2017 and Feb 16, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2026 FOR UNKNOWN REASONS, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 1-2 13MM WAS EXPLANTED AND REPLACED WITH A LGN PS HIGH FLEX XLPE SZ 1-2 9MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24344028 ↗
• InjuryOct 25, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT PRESENTED TO THE DOCTOR AFTER FALL. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A LGN PS HIGH FLEX XLPE SZ 1-2 13MM WAS EXCHANGED WITH A 1/2 X 15MM LEGION XLPE HF INSERT.. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15665713 ↗
• MalfunctionSep 9, 2022Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, A LEGION POLYETHYLENE INSERT SIZE 1-2 13MM FAILED TO BE POSITIONED. UPON ATTEMPTING TO INSERT THE IMPLANT, A LITTLE FLAKY ON THE INSERT WAS CAUSED. NO FLAKES FELL INTO THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393498 ↗
• MalfunctionJan 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON REQUESTED A 1/2 13MM INSERT AND WHEN OPENING THE BOX THE STERILE INSERT WAS A 3/4 11MM INSERT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231201 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN ACCIDENT IN WHICH THE LEGION PS HIGH FLEX XLPE INSERT FRACTURED. THE IMPLANTS WERE NOT DEEMED AS DEFECTIVE BY THE SURGEON. THE INSERT WAS EXPLANTED IN A REVISION SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10158131 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT LEFT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIA COMPONENT.

  Patient problems: Injury

  MAUDE report 8547008 ↗
• InjuryMar 3, 2018Detachment Of Device Component; Detachment Of Device Component

  AS UPDATED BY CUSTOMER, PATIENT IS NOT WILLING TO HAVE THE REVISION SURGERY.

  Patient problems: No Information

  MAUDE report 7312255 ↗
• InjurySep 18, 2017Misconnection; Misconnection

  IT WAS REPORTED THAT A RIGHT TIBIAL REVISION SURGERY WAS PERFORMED DUE TO INSERT NOT ENGAGING WITH THE TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 6874409 ↗

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-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-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