LEGION 71453224Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556033913), received between Sep 12, 2017 and Dec 22, 2025 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 15MM WAS REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23863891 ↗
• InjuryNov 30, 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 ON (B)(6) 2019, THE PATIENT HAD A FALL EVENT AND HAD SIGNS OF INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A WASHOUT WAS PERFORMED AND THE LGN PS HIGH FLEX XLPE SZ 5-6 15MM WAS EXCHANGED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23677072 ↗
• InjurySep 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A TKA WAS PERFORMED ON (B)(6) 2023, THE PATIENT COMPLAINED OF BEING UNABLE TO WALK AND SEVER PAIN, DUE TO THIS, THE PATIENT WAS ADMITTED FOR REVISION SURGERY ON (B)(6) 2024. WHEN SURGEON OPENED THE KNEE JOINT, IT WAS FOUND THE LGN PS HIGH FLEX XLPE SZ 5-6 15MM WAS UNLOCKED AND LOOSE FROM THE TIBIAL BASE PLATE. AS PER PATIENT, HEALTH IS FINE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 20292159 ↗
• InjuryMay 11, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A LGN PS HIGH FLEX XLPE SZ 5-6 15MM FAILED TO BE INSERTED AFTER 6 ATTEMPTS. IRRIGATION/DEBRIDEMENT OF TISSUE WAS MADE AND CEMENT WAS PLACED AROUND THE PROSTHESIS. THE PROCEDURE WAS COMPLETED BY CHANGING TO A CONSTRAINED POLY, WHICH WAS INSERTED ON THE FIRST ATTEMPT. A A NON-SIGNIFICANT DELAY OCCURRED DUE TO THIS ISSUE, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911680 ↗
• InjuryFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT SUSTAINED A POST BREAKAGE OF THE LGN PS HIGH FLEX XLPE SZ 5-6 15MM. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023 TO TREAT THIS COMPLICATION. ANY CLINICAL SYMPTOMS EXPERIENCED BY THE PATIENT ALONG WITH THE IMPLANT FAILURE ARE YET TO BE CONFIRMED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16379946 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT COMPLAINED OF LOOSENESS AND CLICKING IN LEFT KNEE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021 WHERE A LGN PS HIGH FLEX XLPE SZ 5-6 15MM WAS DISCOVERED TO BE BROKEN; THEREFORE, IT WAS EXPLANTED AND CHANGED BY A GNS II CON INS SZ5-6 18MM. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12250246 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED BECAUSE PRESENTED A POSSIBLE INFECTION. NO MORE INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 11099439 ↗
• MalfunctionDec 30, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A REVISION TKA, THE SURGEON WAS PUTTING IN THE LGN PS HIGH FLEX XLPE SZ 5-6 15MM HOWEVER IT WOULD NOT STAY LOCKED INTO THE TIBIAL BASEPLATE. THE SURGEON BELIEVED IT TO BE WARPED ON THE BOTTOM WHERE THE LOCKING MECHANISM WOULD OCCUR. VISUAL CONFIRMATION THAT NO SOFT TISSUE AND/OR BONE CEMENT WAS CAUSING ISSUE. DELAY OF 15MIN. NO HARM INVOLVED. THERE WAS A S&N BACK UP DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094731 ↗
• InjuryOct 20, 2020Break; Break

  IT WAS REPORTED THAT PATIENT HAD S+N COMPONENTS SINCE UNKNOWN DATE AND WHILE TWISTED LEFT KNEE GETTING OUT OF SAND TRAP POST BROKE. 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: Foreign Body In Patient

  MAUDE report 10708097 ↗
• InjurySep 22, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE LEGION PS HIGH FLEX XLPE SIZE 5-6 15MM BROKE. THE IMPLANT WAS REPLACED WITH A PS INSERTER 5-6 18MM.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10564951 ↗
• MalfunctionJun 18, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT DURING SURGERY, RIGHT AFTER REMOVING THE ORIGINAL INSERT, THE SURGEON IMPLANTED A PATELLA AND THOROUGHLY CLEANED AND CLEARED THE TIBIAL BASE PLATE AND SURROUNDING TISSUE TO INSERT THE REPLACEMENT POLY. AFTER 3 FAILED ATTEMPTS TO LOCK DOWN THE POLY A SECOND BACK UP POLY WAS OPENED AND IMPACTED DOWN CORRECTLY ON THE FIRST ATTEMPT. IT IS UNKNOWN IF THERE WAS ANY DELAY NOR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10166208 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A REVISION SURGERY A WASHOUT AND POLY EXCHANGE WERE DONE. IT WAS PERFORMED DUE TO ACUTE INFECTION (CONFIRMED INTRAOPERATIVELY).

  Patient problems: Unspecified Infection

  MAUDE report 9253261 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ARTHROSCOPY WAS PERFORMED DUE TO KNEE EFFUSION AND PAIN AN ADDITIONALLY AN ASPIRATION AND A CORTISONE INJECTION WERE GIVEN A MONTH AFTER.

  Patient problems: Injury; Pain

  MAUDE report 8349341 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER TWO UNSUCCESSFUL ASPIRATION ATTEMPTS DUE TO PAIN AND EFFUSION, A KNEE ARTHROSCOPY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8348538 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS MORE THAN THREE MONTHS STATUS POST HER SURGERY, FAILED TO REGAIN FULL RANGE OF MOTION ON HER RIGHT KNEE. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED AND AN INJECTION FOR PAIN CONTROL POSTOPERATIVELY WAS APPLIED ON HER RIGHT KNEE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8155009 ↗
• InjuryDec 11, 2018Adverse 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 RIGHT KNEE INSTABILITY AND PATELLOFEMORAL IMPINGEMENT. THE PROCEDURE INCLUDED LATERAL RELEASE AND MEDIAL PLICATION OF RIGHT KNEE PATELLOFEMORAL JOINT AND EXCHANGE OF THE POLYETHYLENE LINER.

  Patient problems: Injury

  MAUDE report 8152479 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY FOR LEFT TKR WAS PERFORMED DUE TO STIFFNESS. SCAR TISSUE WAS EXCISED AND THE INSERT WAS EXCHANGED.

  Patient problems: Joint Disorder

  MAUDE report 6859064 ↗

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-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
• 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