LEGION 71453171Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556486849), received between Sep 22, 2017 and Dec 31, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjuryDec 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA SURGERY WAS PERFORMED ON THE (B)(6) 2024, THE PATIENT EXPERIENCED A FALL RESULTING IN AN INSERT DISSOCIATION. THE PATIENT UNDERWENT A REVISION SURGERY ON THE (B)(6) 2024 IN WHICH THE INSERT WAS REPLACED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21047599 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE DOCTOR OBSERVED ELEVATED INFLAMMATION LEVELS IN THE PATIENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY A WEEK LATER, IN WHICH THE LINER WAS REPLACED WITH A DIFFERENT S+N PRODUCT. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20517002 ↗
• InjuryOct 30, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SWELLING AND INFECTION. A REVISION SURGERY AND DEBRIDEMENT WERE PERFORMED ON (B)(6) 2023 TO TREAT THIS ADVERSE EVENT IN WHICH A LGN PS HIGH FLEX XLPE SZ 1-2 10MM WAS EXCHANGED WHILE A LEGION PS OXIN FEM SZ3 RT AND A GII CM TIB SIZE 2 {} RIGHT REMAINED. IN ADDITION, THE SURGEON DOES NOT BELIEVE THAT THE PRODUCT IS AT FAULT. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection; Swelling/ Edema

  MAUDE report 18029366 ↗
• InjuryNov 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL KNEE REPLACEMENT WAS PERFORMED ON AN UNKNOWN DATE, THE POLY DISLOCATED, FOR WHICH A REVISION SURGERY WAS CONDUCTED (IT IS UNCERTAIN IS THIS EVENT WAS ALREADY REPORTED IN THE PAST). SUBSEQUENTLY, THE POLY DISLOCATED AGAIN AND A SECOND REVISION SURGERY WAS INDICATED TO TREAT THIS EVENT. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 15875773 ↗
• MalfunctionJun 26, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THERE WAS A BLACK SPOT ON THE PRODUCT. FINALLY A SAME SIZE PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS A DELAY BETWEEN 30 AND 60 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10199740 ↗
• InjurySep 22, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A REVISION SURGERY DUE TO A FEMORAL FRACTURE, THE INSERT WOULD NOT LOCK INTO THE TIBIAL BASEPLATE. THERE WAS NO SUITABLE BACK-UP AND THE OLD INSERT WAS RE-IMPLANTED.

  Patient problems: Injury

  MAUDE report 6887194 ↗

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-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
• 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