LEGION 71420551Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010555830), received between Sep 10, 2019 and Jul 15, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K230653, K962137); 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.

• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER UNDERGOING A TKA ON AN UNKNOWN DATE, PATIENT EXPERIENCED INSERT DETACHMENT FROM THE TIBIAL COMPONENT. IN ADDITION, THERE WAS LUXATION. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING REVISION SURGERY ON (B)(6) 2014, TO EXCHANGE THE LEGION CON ART INS 9MM SZ 7-8. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Nerve Damage; Rupture; Subluxation

  MAUDE report 19745297 ↗
• InjuryApr 19, 2023Device Dislodged or Dislocated; No Apparent Adverse Event; Device Dislodged or Dislocated; No Apparent Adverse Event

  *US LEGAL CASE* IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON THE (B)(6) 2020, THE PATIENT EXPERIENCED RECURRENT SWELLS AND PAIN WITH WEIGHTBEARING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT, IN WHICH THE POLY INSERT WAS NOTICED TO BE DISASSOCIATED FROM THE TIBIAL BASE PLATE WITH CATASTROPHIC POLY WEAR AND OSTEOLYSIS UNDER THE IMPLANTS. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH COMPETITOR DEVICES. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM AND RECEIVED THERAPY SESSIONS.

  Patient problems: Arthralgia; Inflammation; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16773429 ↗
• InjuryAug 31, 2022Fitting Problem; Adverse Event Without Identified Device or Use Problem; Fitting Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED, PATIENT WAS ENTERED TO HAVE REVISION OF THE PATELLA FEMORAL BONE TO IMPLANT THE GII OVAL RESURFACING PAT 35MM. WHILE DOING THE REVISION, SURGEON DECIDED TO REPLACE THE TIBIAL COMPONENT, HOWEVER, HE SAID IT WAS BEST TO USE A CONSTRAINED PS INSERT INSTEAD OF THE PS HI FLEX THAT WAS CURRENTLY IN USE. THE INITIAL LEGION CON ART INS 9MM SZ 7-8 DID NOT FEEL AT ANY STAGE FULLY SEATED OR LOCKED. AS CONSEQUENCE OF THIS, SURGEON HAD TO USE THE GNS II CON INS SZ7-8 11MM TO FIT, LOCK AND SECURE AS EXPECTED. IT IS UNKNOWN IF SURGERY WAS DELAYED AND PATIENT'S CURRENT HEALTH STATUS.

  Patient problems: Insufficient Information

  MAUDE report 15330278 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON AN (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14407147 ↗
• InjuryMay 5, 2022Adverse 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, A REMOVAL OF LEGION CON ART INS 9MM SZ 7-8 HAD TO BE DONE FOR AN INFECTED KNEE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE INSERT. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14290665 ↗
• InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO PROSTHETIC INFECTION. THE LEGION CON ART INS 9MM SZ 7-8 WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED THE SAME YEAR ON (B)(6) 2017.

  Patient problems: Unspecified Infection

  MAUDE report 10003255 ↗
• InjurySep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LUXATION OF THE PROXIMAL TIBIA DUE TO POST TRAUMATIC EVENTS.

  Patient problems: Injury

  MAUDE report 8981132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230653, K962137. 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-0118-2021 · Sep 21, 2020 · Terminated
  Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e.