LEGION 71420523Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010555823), received between Jul 6, 2017 and Jul 21, 2025 — classified as 14 injuries, 3 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Adverse 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) 2025, THE INLAY DISLOCATED. THIS WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONLY ONE (1) LEGION CON ART INS 9MM SZ 3-4 WAS EXCHANGED. THE PATIENT WAS REPORTED TO BE WELL AFTER THE OPERATION.

  Patient problems: Joint Dislocation

  MAUDE report 22562104 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTED KNEE. TO SOLVE THIS ADVERSE EVENT THE PATIENT WAS WASHED OUT AND THE LEGION CON ART INS 9MM SZ 3-4 WAS EXCHANGED ON (B)(6) 2022. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT CURRENT HEATH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 15834488 ↗
• MalfunctionJun 14, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED, THAT DURING A TKA SURGERY, A LEGION CON ART INS 9MM SIZE 3-4 DID NOT LOCK INTO TIBIA BASES TRAY. SURGERY WAS COMPLETED, WITHOUT DELAY, BY USING A BACK-UP DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995874 ↗
• MalfunctionDec 14, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A REVISION SURGERY OF LEGION PRIMARY CR PROSTHESIS, WHEN TRYING TO EXCHANGE INLAY, A GENESIS II PS INSERT SZ 3-4 11MM WAS USED, BUT IT COULD NOT BE FIXED ON THE TIBIAL BASE. THEN, IT WAS ATTEMPTED TO ANCHOR A LEGION CON ARTICULAR INSERT 9MM SZ 3-4 AND IT ALSO FAILED. THE INLAY COULD NOT BE FIXED AND THE PROCEDURE WAS FINISHED USING THE SAME INLAY IN THE PATIENT. THIS ISSUE CAUSED A DELAY GREATER THAN 30 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001966 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A LEGION CON ART INS 9MM SZ 3-4 WAS EXPLANTED DURING A REVISION SURGERY, WHICH WAS PERFORMED DUE TO INFECTION. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY OR NOT. NO 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: Unspecified Infection

  MAUDE report 10980027 ↗
• InjuryOct 4, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A PRIMARY TKR CASE ON THE RIGHT SIDE, SURGEON TRIED TO IMPLANT A SIZE 3-4 9MM CONSTRAINED LINER AND WAS UNABLE TO ENGAGE THE POLY, DESPITE RECOMMENDATIONS FROM THE REP. DEBRIS WAS CLEARED FROM THE BASEPLATE. SIZING COMPATIBILITY WAS ALSO CHECKED AND CORRECT. DESPITE MULTIPLE ATTEMPTS WAS UNABLE TO GET THE LINER IN. IT WAS CHANGED TO POSTERIOR STABILIZED LINER AND THERE WAS NO ISSUES ENGAGING THE POLY AND SURGEON WAS ABLE TO DO SO ON FIRST ATTEMPT. SURGERY WAS NOT DELAYED MORE THAN 30 MINUTES. NO OTHER COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10624760 ↗
• InjuryOct 4, 2020Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A PRIMARY TKR CASE ON THE RIGHT SIDE, SURGEON TRIED TO IMPLANT A SIZE 3-4 9MM CONSTRAINED LINER AND WAS UNABLE TO ENGAGE THE POLY, DESPITE RECOMMENDATIONS FROM THE REP. DEBRIS WAS CLEARED FROM THE BASEPLATE. SIZING COMPATIBILITY WAS ALSO CHECKED AND CORRECT. DESPITE MULTIPLE ATTEMPTS WAS UNABLE TO GET THE LINER IN. IT WAS CHANGED TO POSTERIOR STABILIZED LINER AND THERE WAS NO ISSUES ENGAGING THE POLY AND SURGEON WAS ABLE TO DO SO ON FIRST ATTEMPT. SURGERY WAS NOT DELAYED MORE THAN 30 MINUTES. NO OTHER COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10624758 ↗
• InjurySep 29, 2020Adverse 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 ON (B)(6) 2016, THE PATIENT DEVELOPED SCAR TISSUE DUE TO ARTHROFIBROISIS. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT: THERE WAS NO INDICATION OF INFECTION. THE INSERT 9MM WAS REMOVED TO GAIN ACCESS TO THE BACK OF KNEE, AND WAS REPLACED WITH SIZE 9 PSHF POLY. IT WAS NOTED AT COMPLETION THAT RANGE OF MOTION WAS GREATER THAN PRE-OPERATIVELY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Fibrosis; Loss of Range of Motion; Scarring

  MAUDE report 10603951 ↗
• InjurySep 29, 2020Adverse 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 ON (B)(6) 2016, THE PATIENT HAD STIFFNESS. A REVISION SURGERY WAS PERFORMED TO WASHOUT AND DEBRIDE THE KNEE. AN INCREASE IN RANGE OF MOTION WAS ACHIEVED; NONETHELESS, SCAR TISSUE FORMED AGAIN AFTER SURGERY.

  Patient problems: Loss of Range of Motion

  MAUDE report 10603880 ↗
• MalfunctionJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEGION CONSTRAINED INSERTS WERE A MIXTURE OF SOME LABELLED GENESIS CONSTRAINED AND SOME LABELLED LEGION CONSTRAINED WITHIN A RUN OF SIZES. TRADITIONALLY THE GII CONSTRAINED LINERS ARE ONLY FOR USE WITH LEGION (BUILT IN ROTATION AFFECTS CONGRUENCY WITH POST), BUT HAVING THEM LABELLED AS GII IS CAUSING SOME STRONG CHALLENGES FROM SURGEONS WHO INSIST THEY CAN USE THEM WITH GII PS FEMURS (¿THEY SAY GENESIS SO CAN USE WITH GENESIS¿).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580367 ↗
• InjuryOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9168996 ↗
• InjuryAug 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO INSTABILITY. A ZIMMER PRODUCT WAS IMPLANTED INSTEAD. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: Injury

  MAUDE report 8929126 ↗
• InjuryMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE SURGEON PERFORMED A MUA AND WAS ABLE TO RELOCATE THE KNEE INTO IT'S PROPER POSITION. HOWEVER, HE WAS NOT HAPPY WITH STABILITY. DR OPENED THE KNEE AND WHEN GOING THROUGH A RANGE OF MOTION HE EXTERNAL ROTATED THE AND THE FEMUR JUMPED THE POST.

  Patient problems: Injury

  MAUDE report 8395484 ↗
• InjuryMar 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR REVISED GEN 2 CR TKR TO A LEGION REVISION FEMUR, CONSTRAINED INSERT ( COMPROMISED LATERAL COLLATERAL) AND KEPT THE ORIGINAL TIBIAL BASEPLATE. WHILE THE PATIENT WAS DOING THEIR PHYSIO ( LEG EXTENSION ) THE FEMUR JUMPED THE POST ON THE POLY. THE SURGEON PERFORMED A MUA AND WAS ABLE TO RELOCATE THE KNEE INTO IT'S PROPER POSITION. HOWEVER, HE WAS NOT HAPPY WITH STABILITY. DR OPENED THE KNEE AND WHEN GOING THROUGH A RANGE OF MOTION HE EXTERNAL ROTATED THE AND THE FEMUR JUMPED THE POST. THE POLY WAS UPSIZED TO A 13MM CONSTRAINED INSERT, AND STABILITY WAS REGAINED.

  Patient problems: Injury

  MAUDE report 8395301 ↗
• InjuryOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REMOVE THE IMPLANTS FROM THE PATIENT DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8017384 ↗
• InjuryDec 6, 2017Detachment Of Device Component; Adverse Event Without Identified Device or Use Problem; Detachment Of Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OF SMITH AND NEPHEW KNEE IMPLANTS.

  Patient problems: Injury

  MAUDE report 7089252 ↗
• InjuryJul 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A RIGHT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

  Patient problems: Injury

  MAUDE report 6688815 ↗

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.