LEGION 71453174Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556486993), received between Nov 20, 2017 and Mar 7, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2026Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST OF THE LGN PS HIGH FLEX XLPE SZ 3-4 12MM. THIS ADVERSE EVENT WAS SOLVED BY A TKA REVISION SURGERY ON (B)(6) 2026, IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 24539885 ↗
• InjuryFeb 28, 2025Adverse 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 A PERIPROSTHETIC JOINT INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A DAIR, IN WHICH A POLY EXCHANGE WAS PERFORMED AS PART OF WASHOUT ON (B)(6)2025. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN

  Patient problems: Medical device site infection

  MAUDE report 21496340 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED INSTABILITY. THEREFORE, A REVISION SURGERY HAS BEEN SCHEDULED TO REVISE THE GN PS HIGH FLEX XLPE SZ 3-4 12MM. PATIENTS CURRENT HEALTH STATUS IS UNKNOWN. REVISION SURGERY DATE TO BE PERFORMED, IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12424632 ↗
• MalfunctionMay 20, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A TKA, THE LEGION PS HIGH FLEX XLPE SIZE 3-4 12MM WOULD NOT SEAT INTO TIBIA BASE TRAY. BACKUP ITEM WAS OPENED AND SEATED CORRECTLY. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860137 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED TWO YEARS AGO, THE PATIENT EXPERIENCED STIFFNESS AND LACK OF ROM. A REVISION SURGERY WAS DONE TO ADDRESS THE ADVERSE EVENT: THE SURGEON DID SOFT TISSUE RELEASES AND BALANCING, AND THEN EXCHANGED THE INSERT. THE OUTCOME IS FINE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11440921 ↗
• MalfunctionFeb 3, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY THE LEGION PS SIZE 3-4MM, 12MM XLPE INSERT WAS NOT LOCKING PROPERLY UPON USUAL IMPACTION METHODS. THE PROCEDURE WAS COMPLETED WITH LESS THAN OR 30 MINS DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271700 ↗
• InjuryAug 19, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A GENESIS II TKR THE SURGEON WAS UNABLE TO LOCK A SIZE 3-4 12MM PS INSERT INTO A SIZE 3 TIBIAL BASEPLATE. IMPLANT WAS CHECKED BEFORE OPENING AND IT WAS THE CORRECT IMPLANT. THE SURGEON ENSURED THERE WAS NO BLOOD/DEBRIS IN THE WAY AND TRIED AGAIN. HE WAS STILL NOT SUCCESSFUL. THERE WAS NOT A SECOND IMPLANT AT THE HOSPITAL AND THERE WAS A DELAY WHILE A NEW ONE WAS SENT FROM THE OFFICE. DURING THE DELAY THE SURGEON TRIALLED A 13MM INSERT AND DECIDED THAT WAS A GOOD CHOICE. THE SIZE 3-4 13MM LOCKED INTO THE SIZE 3 TIBIA THE FIRST TIME WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10428236 ↗
• InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE AN INFECTION. A POLY WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 8236348 ↗
• InjuryJun 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO KNEE JOINT PSEUDARTHROSIS. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS WAS RETURNED TO THE PATIENT AFTER THE SURGERY SO IT CANNOT BE RETURNED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7564067 ↗
• InjuryMar 12, 2018Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO THE POLY DISLODGED.

  Patient problems: No Code Available

  MAUDE report 7332813 ↗
• InjuryNov 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION OF INSERT. IT WAS A TECHNICAL ERROR SO THE SURGEON DOESN'T THINK PRODUCTS FAILURE.

  Patient problems: Injury

  MAUDE report 7046601 ↗

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-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
• 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