LEGION 71453233Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885556033524), received between Dec 6, 2018 and Jul 13, 2026 — classified as 29 injuries.

The most frequently reported specific device problem is “Fracture” (10 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED A FRACTURE OF ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE INSERT WAS REPLACE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25807782 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS EXCHANGED AFTER DAIR. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 25502294 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON 2024, PATIENT EXPERIENCED A PROSTHETIC JOINT INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH A WASHOUT AND POLY INSERT EXCHANGE WAS PERFORMED. ONLY 1 COMPONENT INVOLVED IN THIS REVISION. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 25089746 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2026, DURING WHICH A KNEE WASHOUT WAS PERFORMED, AND THE LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 24605293 ↗
• InjuryFeb 2, 2026Fracture

  IT WAS REPORTED THAT, FOLLOWING A TKA PERFORMED MORE THAN 10 YEARS AGO, THE PATIENT FELL AND LANDED ON THE KNEE. THIS EVENT WAS ADDRESSED WITH REVISION SURGERY ON (B)(6) 2026, DURING WHICH IT WAS DISCOVERED THAT THE POST OF ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS BROKEN. THE INSERT WAS REPLACED WITH A SIZE 7-8, 13 MM THICKNESS INSERT. THE SURGEON WAS REPORTEDLY PLEASED WITH THE POSTOPERATIVE CONDITION OF THE KNEE. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fall

  MAUDE report 24233683 ↗
• InjuryAug 27, 2025Adverse 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 IN (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO AN INFECTION. A WASHOUT WAS PERFORMED AND ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22904011 ↗
• InjuryMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A BREAKAGE OF ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH IMPLANT AND BROKEN PIECE WERE RETRIEVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21976750 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THE SURGEON DECIDED TO WASHOUT THE JOINT AND REPLACE THE LGN PS HIGH FLEX XLPE SZ 7-8 13MM ON (B)(6) 2024. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19639228 ↗
• InjuryJun 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER TKA SURGERY, THE PATIENT PRESENTED WITH AN UNSTABLE KNEE, FROM X-RAYS AND CLINICAL INVESTIGATION, IT SEEMED AS IF THE PEG OF THE LGN PS HIGH FLEX XLPE SZ 7-8 13MM BROKE. ON (B)(6) 2024 THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE BREAKAGE WAS CLEAR, AND THE INSERT WAS EXCHANGED WITH A NEW XLPE PS INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19514906 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED A TOOTH INFECTION. THE DOCTOR STATED THAT THIS CAUSED THEIR KNEE TO SWELL AND BECOME INFECTED. THIS ADVERSE EVENT WAS TREATED ON 16-DEC-2023, IN WHICH THE JOINT WAS WASHED OUT AND DEBRIDED. A NEW LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS PLACED IN EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection; Swelling/ Edema

  MAUDE report 18478193 ↗
• InjuryOct 25, 2023Break; Break

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO CHANGE THE LGN PS HIGH FLEX XLPE SZ 7-8 13MM DUE TO BEING BROKEN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18006978 ↗
• InjuryJul 20, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND BROKE THE POST ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 13MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. INSERT WAS REPLACED WITH A PS POLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 17358464 ↗
• InjuryJun 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR PERFORMED ON 2013, PATIENT HAD A BROKEN POST FROM HIS LGN PS HIGH FLEX XLPE SZ 7-8 13MM AFTER A FALL. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY IN WHICH A SMITH AND NEPHEW SAME SIZE INSERT WAS IMPLANTED. HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 17137072 ↗
• InjuryMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6)2014, THE PATIENT SAID HIS KNEE DIDN'T FEEL STABLE. UPON EXAMINATION IN A REVISION SURGERY, IT WAS NOTICED THE POLY POST HAD BROKEN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS EXPLANTED AND EXCHANGED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 16947898 ↗
• InjuryMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCIENTIFIC PAPER MEETING FROM THE (B)(6) ASSOCIATION HELD ON (B)(6) 2023. FROM ONE ABSTRACT TITLED ¿TIBIAL POST FRACTURE IN LEGION AND GENESIS II POSTERIOR STABILIZED TOTAL KNEE REPLACEMENTS¿, 1 PATIENT SUSTAINED REVISION SURGERY ON THE RIGHT KNEE ON (B)(6) 2022 DUE TO TIBIAL POST FRACTURE OF A LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 13MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16644768 ↗
• InjuryMar 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCIENTIFIC PAPER MEETING FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION HELD ON (B)(6) 2023. FROM ONE ABSTRACT TITLED ¿TIBIAL POST FRACTURE IN LEGION AND GENESIS II POSTERIOR STABILIZED TOTAL KNEE REPLACEMENTS¿, 1 PATIENT SUSTAINED REVISION SURGERY ON THE LEFT KNEE ON (B)(6) 2022 DUE TO TIBIAL POST FRACTURE OF A LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 13MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16644733 ↗
• InjuryJan 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN 2013, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH IT WAS FOUND THAT THE POST OF A LGN PS HIGH FLEX XLPE SZ 7-8 13MM HAD BROKEN OFF. THE INSERT WAS REPLACED WITH ANOTHER ONE WITH THE SAME EXACT CHARACTERISTICS. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 16265312 ↗
• InjuryApr 19, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVED OF LGN PS HIGH FLEX XLPE SZ 7-8 13MM DUE TO SUSPECTED BROKEN POST. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14142070 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST LEFT KNEE TKA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021 (CASE (B)(4)), THE PATIENT EXPERIENCE UNSPECIFIED DEEP INFECTION AND LEG ERYTHEMA THAT WAS ADDRESSED VIA A SECOND REVISION SURGERY ON (B)(6) 2021. A LGN PS HIGH FLEX XLPE SZ 7-8 13MM WAS REPLACED AND THE EXPLANTED DEVICE WAS SENT OFF TO PATHOLOGY, THEREFORE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 13052530 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO A KNEE INFECTION, A REVISION SURGERY WAS PERFORMED, WERE A 7-8 13MM LEGION PS HI FLEX ART INSERT WAS REPLACED. SURGERY WAS COMPLETED BY USING A BACK-UP DEVICE, WITHOUT A SIGNIFICANT DELAY. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12516887 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE POST OF THE IMPLANTED LGN PS HIGH FLEX XLPE SZ 7-8 13MM BROKE OFF. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE BROKEN INSERT WAS RETRIEVED FROM THE PATIENT'S KNEE, AND REPLACED WITH A NEW ONE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12475341 ↗
• InjuryMar 21, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED 6 YEARS AGO, THE PATIENT EXPERIENCED A FRACTURE OF THE LGN PS HIGH FLEX XLPE SZ 7-8 13MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. THE DEVICE WAS EXPLANTED. THE CURRENT STATUS OF PATIENT¿S HEALTH IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11536924 ↗
• InjuryNov 26, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE POST OF LGN PS HIGH FLEX XLPE SZ 7-8 13MM INSERT BROKE. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10912599 ↗
• InjuryMay 12, 2020Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE POST OF A SIZE 7-8 13 MM LEGION PS HIGH FLEX XLPE INSERT BROKE. THE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY TO EXCHANGE SUCH INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10048054 ↗
• InjuryApr 10, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE PATIENT HAD SMITH+NEPHEW COMPONENTS SINCE AN UNKNOWN DATE. REVISION SURGERY, A RADICAL SYNOVECTOMY AND WASHOUT WERE PERFORMED DUE TO INSTABILITY AND ONGOING KNEE EFFUSION. ALSO, THE INSTABILITY WAS ADDRESSED USING THE 15MM INSERT.

  Patient problems: Injury

  MAUDE report 9950962 ↗

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-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-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-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