LEGION 71453223Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885556033425), received between Nov 7, 2017 and Jan 13, 2026 — classified as 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Fracture

  IT WAS REPORTED THAT AFTER A TKA PERFORMED AT AN UNKNOWN DATE, A REVISION SURGERY TOOK PLACE ON (B)(6) 2025 DUE TO THE POST OF THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM BREAKING OFF, THOUGH NOT VISIBLE ON X-RAY. AT THIS TIME, ANY FURTHER DETAILS ARE UNKNOWN. PATIENT STATUS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 24050222 ↗
• InjuryJan 5, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT WAS KNEELING AND HEAR A POP, AND IT WAS FOUND THAT ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 13MM BROKE OFF. THE PATIENT WAS VERY ACTIVE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Discomfort; Insufficient Information; Radiolucent Lines

  MAUDE report 23955877 ↗
• InjuryJun 19, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM WAS EXCHANGED. THE PATIENT LEFT IN GOOD HEALTH.

  Patient problems: Insufficient Information

  MAUDE report 22289617 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE AT AN UNKNOWN DATE, A REVISION SURGERY TOOK PLACE ON (B)(6)2025 TO REMOVED THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM DUE TO A SUSPECTED INFECTION. IT WAS REPLACED BY AN IMPLANT OF THE SAME SIZE. PATIENT STATUS UNKNOWN AT THIS TIME.

  Patient problems: Medical device site infection

  MAUDE report 21301556 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA WAS PERFORMED ON AN UNKNOWN DATE, ON (B)(6) 2025 A LGN PS HIGH FLEX XLPE SZ 5-6 13MM WAS REPLACED, DUE TO SUSPECTED INFECTION, DURING SURGERY, AN EXTENSIVE WASHOUT WAS PERFORMED AND POLY WAS REPLACED WITH A NEW SAME THICKNESS POLY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21293737 ↗
• InjuryNov 26, 2024Adverse 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 ON (B)(6) 2013, THE PATIENT HYPERFLEXED AND TWISTED HIS KNEE INTO VARUS IN (B)(6) 2015, FROM A WRESTLING MANEUVER. IT SETTLED WITHOUT ANY INTERVENTION. THE PATIENT HAD A SIMILAR INJURY IN (B)(6) 2016, WHICH REQUIRED AN MUA TO REDUCE A POST-CAM JUMP (DISLOCATION). THE PATIENT RECOVERED WELL.

  Patient problems: Hyperextension; Joint Dislocation

  MAUDE report 20777342 ↗
• InjuryJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH A BROKEN LGN PS HIGH FLEX XLPE SZ 5-6 13MM POST. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DURING WHICH THE INSERT WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19500022 ↗
• InjuryApr 25, 2024Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION OF A PRIMARY TKA, THE PATIENT EXPERIENCED AGAIN LAXITY AND LOOSE PATELLA. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM AND PATELLA. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19183377 ↗
• InjuryApr 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT,A PATIENT PRESENTED WITH A LOCKING KNEE, IT WAS FOUND THAT THE POST OF THE LGN PS HIGH FLEX XLPE SZ 5-6 13MM BROKE, AND THE KNEE WAS LOCKING UP DUE TO THE BROKEN POST. THEREFORE A REVISION SURGERY WAS PERFORMED ON 02-APR-2024. FURTHER COMPLICATIONS WERE NOT REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19164721 ↗
• InjuryJan 3, 2024Adverse 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) 2023, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 18436965 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAS BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A INCREASED KNEE PAIN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY IN WHICH THE SURGEON DECIDED TO RESURFACE THE PATELLA AND EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 5-6 13 MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14018388 ↗
• InjuryApr 9, 2021Break; Break

  IT WAS REPORTED THAT, AFTER PATIENT COMPLAINED OF CLUCKING WHEN BENDING KNEE, SURGEON REVISED AND FOUND A BROKEN POST ON TIBIAL INSERT THEREFORE SURGEON REPLACED WITH NEW 5-6 13MM INSERT. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant

  MAUDE report 11644215 ↗
• 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 13MM HOWEVER IT WOULD NOT STAY LOCKED INTO THE TIBIAL BASEPLATE. AFTER MULTIPLE TIMES, IT WAS CONFIRMED NOTHING WAS BLOCKING THE POLY AND THE POLY APPEARED TO BE WARPED ON THE BACKSIDE. ANOTHER POLY WAS OPENED WHICH LOCKED IN PLACE. SURGICAL DELAY OF 15 MIN. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094740 ↗
• MalfunctionAug 20, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP FOR TKA PROCEDURE DEVICE DOES NOT FIT CORRECTLY WITH THE TIBIA BASEPLATE. PROCEDURE WAS COMPLETED WITH DELAY NO MORE THAN 30 MINUTES USING AN SMITH&NEPHEW BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434991 ↗
• MalfunctionAug 20, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP FOR TKA PROCEDURE DEVICE DOES NOT FIT CORRECTLY WITH THE TIBIA BASEPLATE. PROCEDURE WAS COMPLETED WITH DELAY NO MORE THAN 30 MINUTES USING AN SMITH&NEPHEW BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10434887 ↗
• InjuryAug 18, 2020Break; Break

  IT WAS REPORTED THAT, 7 MONTHS AFTER A PRIMARY RIGHT TKR WAS PERFORMED, THE PATIENT STARTED SUFFERING FROM SUFFERING FROM PAIN, SWELLING, POPPING, AND LOCKING OF THE KNEE. DUE TO THIS, THE PATIENT WAS SCHEDULED FOR AN ARTHROSCOPIC EVALUATION OF THE KNEE. DURING THE EVALUATION, THE SURGEON DECIDED TO CHANGE THE PROCEDURE TO AN OPEN REVISION. THE SWAP ON THE INSTRUMENT HAPPENED DUE TO THE KNEE WAS UNSTABLE AND THE DOCTOR WANTED TO ADD THICKNESS TO THE POLY TO STABILIZE THE JOINT. WHEN THE INCISION WAS MADE AND GOT TO THE JOINT, IT WAS NOTICED THAT THE POST FROM THE POLY INSERT THAT WAS IMPLANTED ON 6-FEB-2019 HAD BROKEN. NO DELAY REPORTED. THE PROCEDURE WAS COMPLETED USING THE NEW POLY.

  Patient problems: Failure of Implant; Injury; Joint Laxity

  MAUDE report 10423451 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY FOR AN INFECTION, FOR THAT REASON ALL THE IMPLANTS WERE REMOVED AND IT WAS IMPLANTED A NEW CEMENT MOLD AND A POLY TIBIA. THE SURGEON REPORTS THAT THE IMPLANTS DID NOT INFLUENCE THE DEVELOPMENT OF THE INFECTION. 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 10237686 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT HAD A BILATERAL TKR PERFORMED. RECENTLY PATIENT PRESENTED WITH PAIN AND INFECTION ON HIS RIGHT SIDE TKR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO CORRECT THE ISSUE. ALL THE IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9992026 ↗
• InjuryOct 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION TKR WAS PERFORMED TO RESURFACE A PATELLA THAT HAD NOT BEEN REPLACED ON PRIMARY TKR, ( PRIMARY TKR PERFORMED 7YEARS AGO), POLY WAS EXCHANGED WHILST PERFORMING THE REVISION SURGERY, POLY NOTED TO HAVE UNUSUAL WEAR PATTERN AND YELLOW STAINING. THE SURGEON REQUESTED THE POLY BE SENT FOR INVESTIGATION OF THE STAINING AND WEAR PATTERN TO DETECT ANY ABNORMALITIES.

  Patient problems: Injury

  MAUDE report 9161743 ↗
• InjuryApr 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. SURGEON FOUND POLY AND TIBIA LOOSED. ALL IMPLANTS WHERE REMOVED AND REPLACED.

  Patient problems: Pain

  MAUDE report 8559555 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION OF A JOURNEY UNI KNEE WAS PERFORMED AND SUCCESSFULLY REVISED IT TO A PRIMARY LEGION P/S KNEE.

  Patient problems: Injury

  MAUDE report 8305925 ↗
• InjuryNov 14, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BROKEN POST. NEW INSERT WAS PUT IN PLACE.

  Patient problems: Injury

  MAUDE report 8069427 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ASPIRATION OF FLUID WAS REQUIRED DUE TO SWELLING.

  Patient problems: Injury

  MAUDE report 7953846 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 7952868 ↗
• InjuryMay 8, 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 FAULTY CEMENT AND MECHANISM.

  Patient problems: Injury

  MAUDE report 7494734 ↗

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-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
• 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