LEGION 71453121Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556033982), received between Jun 15, 2017 and May 28, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A LGN CR HIGH FLEX XLPE SZ 5-6 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 25316905 ↗
• InjuryMar 1, 2024Adverse 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) 2023, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024 IN WHICH THE LGN CR HIGH FLEX XLPE SZ 5-6 9MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18816452 ↗
• MalfunctionNov 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, THE STERILE PACKAGING OF ONE (1) LGN CR HIGH FLEX XLPE SZ 5-6 9MM WAS COMPROMISED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118645 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2023, DOCTOR DID A WASHOUT ON (B)(6) 2023 DUE TO INFECTION, AND HE REPLACED THE LGN CR HIGH FLEX XLPE SZ 5-6 9MM. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17986162 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING TKA ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH A POSSIBLE INFECTION. THIS EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2023, IN WHICH THE LEGION CR HIGH FLEX XLPE SZ 5-6 9MM WAS REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17743896 ↗
• InjuryApr 28, 2022Adverse 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, THE IMPLANTS WERE REMOVED DUE TO SUSPECTED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN CR HIGH FLEX XLPE SZ 5-6 9MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14246952 ↗
• MalfunctionSep 29, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, IT WAS FOUND THAT THE SEALING OF THE STERILE POUCHES OF A LGN CR HIGH FLEX XLPE SZ 5-6 9MM WAS ALREADY BROKEN. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551028 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO YEARS AFTER A BILATERAL TKA, THE PATIENT COMPLAINED OF INSTABILITY ON THE LEFT KNEE. PATIENT SUFFERED FROM OBESITY, AND HAD DIFFICULTY IN HOLDING THE LEG, ASSESSING STABILITY AND HYPEREXTENSION. A REVISION SURGERY WAS PERFORMED TO EXPLANT A LGN CR HIGH FLEX XLPE SZ 5-6 9MM. THE LINER WAS REPLACED. ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 11484444 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LEGION CR HIGH FLEX XLPE SIZE 5-6 9MM PLASTIC BROKE. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED. NO HARM OR INJURY REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165681 ↗
• InjurySep 1, 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, THE PATIENT HAD INFECTION. SURGEON ELECTED TO DEBRIDE, WASH-OUT AND EXCHANGE ARTICULAR INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10480643 ↗
• InjuryJun 5, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE POLY WAS EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10123217 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AN INFECTION ON THE KNEE. A REVISION SURGERY AND A WASH OUT WERE PERFORMED TO CORRECT THE ISSUE. POLY WAS SWAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 10077176 ↗
• InjuryOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS TREATED DUE TO LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9253244 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A DEEP VEIN THROMBOSIS. THE EVENT WAS RESOLVED VIA MEDICATION.

  Patient problems: Injury

  MAUDE report 9253238 ↗
• InjuryAug 22, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT SURGEON NOTICED FIXED FLEXION OF ABOUT 10-15 DEGS, PATIENT APPARENTLY COMPLAINING THAT POST AND CAM "CLICKING" ON AMBULATION, POSSIBLE MAL ROTATION OF FEMUR/TIBIA PROSTHESIS. CR TRIAL REDUCTION PERFORMED INTRA OPERATIVELY. STABILITY OF THE KNEE WAS ACHIEVED AND THAT ITS THE BEST OPTION FOR THE MOMENT INSTEAD OF DOING A FULL FEMORAL AND TIBIAL REVISION. CR INSERT USED (INSTEAD OF PS)

  Patient problems: Injury

  MAUDE report 8920299 ↗
• InjuryNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DOCTOR REMOVED A GII KNEE FROM PATIENT DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8071185 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO STIFFNESS.

  Patient problems: Muscular Rigidity

  MAUDE report 7929014 ↗
• InjurySep 5, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A REVISION SURGERY IN WHICH POLY WAS RETRIEVED DUE TO IT WAS SHOWING SIGNS OF POSSIBLE PITTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845380 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 7724626 ↗
• InjuryJul 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7684034 ↗
• InjuryMay 7, 2018Connection Problem; Connection Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT LOOSENING.

  Patient problems: Injury

  MAUDE report 7490351 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION SURGERY WAS PERFORMED DUE TO ACUTE SEPTIC KNEE. THE INSERT WAS REMOVED, KNEE WASHED OUT AND A NEW INSERT IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6644103 ↗

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-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-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-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-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