LEGION 71420537Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555809), received between May 14, 2018 and Sep 30, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT AFTER A TOTAL KNEE REPLACEMENT THAT TOOK PLACE ON (B)(6) 2025, THE LEGION CON ART INS 9 MM SZ 5-6 CAME LOOSE, CAUSING PAIN. A REVISION SURGERY TOOK PLACE ON (B)(6) 2025 TO EXPLANT THE LEGION CON ART INS 9 MM SZ 5-6, ALONG WITH THE LGN OX CONSTRAINED FEM 5 LT, THE LGN REV TIBIA BASE SZ 5 LT, TWO (2) LGN SCRW DIS FEM WDG SZ5 5 MMS, THE GNS II RESURF PAT 32 MM, THE LGN PRESSFIT STEM 13 MM X 160 MM, THE LGN PRESSFIT STEM 15 MM X 160 MM, AND THE LGN OFFSET COUPLER 4 MM. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 23177527 ↗
• InjuryMar 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT PRIMARY TEP HAD BEEN PERFORMED ON (B)(6) 2022 WITH VARUS GONARTHROSIS OF THE RIGHT KNEE AND LIGAMENTOUS INSUFFICIENCY AS THE PRIMARY DIAGNOSIS, THE PATIENT SUSTAINED THE ANTERIOR SUBLUXATION OF THE INLAY AFTER MULTIPLE FALLS AT HOME BETWEEN MARCH AND APRIL 2022. AFTER AN OFFICE VISIT CONDUCTED ON (B)(6) 2022, THE TREATING SURGEON RECOMMEND THE INLAY EXCHANGE DUE TO PERSISTENT JOINT INSTABILITY AND PAIN. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ARTICULAR INSERT WAS EXPLANTED AND REPLACED WITH A NEW LEGION 9MM INSERT. INTRAOPERATIVELY, THE INLAY WAS COMPLETELY TORN OUT OF ITS ANCHORAGE AND WAS REMOVED WITHOUT PROBLEMS. THE PROCEDURE WENT UNEVENTFULLY, AND THE PATIENT WAS DISCHARGED WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: Arthralgia; Fall; Joint Laxity; Pain; Subluxation

  MAUDE report 16492952 ↗
• InjuryFeb 15, 2023Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT TKA REVISION WITH INLAY EXCHANGE HAD BEEN PERFORMED ON (B)(6) 2022 DUE TO RIGHT KNEE JOINT STABILITY AND SUBLUXATION DUE TO MULTIPLE FALLS, THE PATIENT SUSTAINED A MECHANICAL COMPLICATION OF THE RIGHT KNEE PROSTHESIS WITH INLAY LOOSENING, PERSISTENT JOINT PAIN AND SYNOVITIS THAT MADE NECESSARY A SECOND TKA REVISION SURGERY TO EXCHANGE ONE (1) LEGION CON ART INS 9MM SZ 5-6 TO A 11MM LEGION CONSTRAINED INLAY. AN ARTHROTOMY AND PARTIAL SYNOVECTOMY WERE ALSO PERFORMED DURING THIS PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT ANY COMPLICATIONS. HIS CURRENT HEATH STATUS WAS REPORTED AS GOOD.

  Patient problems: Arthralgia; Failure of Implant; Joint Laxity; Scar Tissue; Synovitis

  MAUDE report 16379159 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020, WHEN A COMPETITOR'S DEVICE WAS REPLACED WITH A S+N PRODUCT. ANOTHER REVISION WAS PERFORMED ON (B)(6) 2020, IN WHICH THE POLY INSERT WAS EXPLANTED AND REPLACED BECAUSE IT WAS DISSOCIATED WITH THE TIBIA BASE PLATE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10804388 ↗
• InjuryAug 3, 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 PERFORM DUE TO POSTERIOR SUBLUXATION OF THE FEMUR FROM THE TIBIA IN A PARTICULAR RANGE OF MOTION. UPON FURTHER EXAMINATION, THE SURGEON WAS ABLE TO CONCLUDE THAT THE POLY INSERT HAD BECOME DISASSOCIATED FROM THE TIBIAL TRAY. NO FURTHER ISSUES DURING THE REVISION. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10356017 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PROCEDURE TKA IN REVISION SURGERY, IT WAS HAD TO REVISE A CONSTRAINED POLY BECAUSE IT HAD BECOME DISASSOCIATED FROM THE TIBIAL TRAY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 10240882 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8844602 ↗
• InjuryMay 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF REVISION DISLOCATION OF KNEE + 6 MONTHS CONVERSION TO HINGE. NO IMPLANTS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 7509837 ↗

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.