LEGION 71453175Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556487044), received between Nov 2, 2018 and Dec 23, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 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) 2025, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 10MM WAS EXCHANGED AFTER A WASHOUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23877736 ↗
• InjurySep 13, 2025Adverse 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) 2019, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 10MM WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 23047540 ↗
• MalfunctionOct 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE INTERNAL PACKAGING OF THE LGN PS HIGH FLEX XLPE SZ 5-6 10MM WAS NOT GLUED PROPERLY AND PRODUCT COULD NOT BE CONSIDERED STERILE. THE PEEL OFF TOP HAD GLUE AROUND 1/3RD OF IT, THE TOP WAS NOT SECURED TO THE PACKING CORRECTLY AND MADE IT OUT INTO THE FIELD. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488113 ↗
• MalfunctionJul 1, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE STERILE PACKAGING OF ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 10MM WAS FOUND TO BE NOT PROPERLY SEALED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649329 ↗
• InjuryMay 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE POST OF THE LGN PS HIGH FLEX XLPE SZ 5-6 10MM BROKE WHILE HE WAS DOING PHYSIOTHERAPY. DUE TO THIS, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER DETAILS AVAILABLE AT THIS MOMENT.

  Patient problems: Failure of Implant

  MAUDE report 16897940 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A LEFT LEGION KNEE REVISION WAS SCHEDULED FOR (B)(6) 2022. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE AT THIS MOMENT

  Patient problems: Insufficient Information; Loss of Range of Motion

  MAUDE report 15307377 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, WHERE A WASHOUT WAS PERFORMED AND THE LGN PS HIGH FLEX XLPE SZ 5-6 10MM WAS EXPLANTED AND EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15136364 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. THE LEGION¿ PS HIGH FLEX XLPE INSERT SIZE 5-6 WAS INSERTED, THE PATIENT'S INCISION OPENED UP APPROXIMATELY FOUR WEEKS AFTER. THIS ADVERSE EVENT WAS SOLVED BY WASHING OUT THE PATIENT AND INSERTING A NEW LEGION¿ PS HIGH FLEX XLPE INSERT SIZE 5-6 ON (B)(6) 2021.

  Patient problems: Wound Dehiscence

  MAUDE report 12159298 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO PATIENT HAD STIFF KNEE WITH ARTHROFIBROSIS. TIBIAL INSERT WAS DOWNSIZED BY ONE MM AND A 5-6 9MM HI FLEX INSERT INSERTED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2021.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 11612118 ↗
• MalfunctionDec 29, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A LEFT TKR, LEGION POSTERIOR HIGH FLEX XLPE SZ 5-6 10MM WOULD NOT LOCK IN TIBIAL TRAY. SURGEON HIT THE IMPLANT MULTIPLE TIMES BUT STILL, IT WOULD NOT SEAT OR LOCK. PROCEDURE CONTINUED WITH A BACKUP DEVICE OF THE SAME SIZE FROM SMITH AND NEPHEW AND WITHOUT AN INJURY. IT IS UNKNOWN IF A DELAY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087579 ↗
• InjuryAug 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED A REVISION SURGERY PERFORMED DUE TO PERSISTENT PAIN AND STIFFNESS. INSERT SIZE INCREASED TO SIZE 12. NEW 29 MM BICONVEX PATELLA IMPLANTED.

  Patient problems: Injury

  MAUDE report 8940110 ↗
• InjuryNov 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 1ST STAGE REVISION OF A GENESIS II TKR FROM 2004 WAS PERFORMED. IT WAS REVISED DUE TO INFECTION. EARLY THIS YEAR, THE KNEE WAS WASHED OUT, AND THE POLYETHYLENE WAS REVISED IN AN ATTEMPT TO CLEAR THE INFECTION. THIS WAS ULTIMATELY UNSUCCESSFUL. ORIGINAL OP NOTES ARE NOT AVAILABLE, SO LOT NUMBERS ETC ARE UNAVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8034893 ↗

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-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-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-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