LEGION 71453222Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00885556035351), received between May 14, 2018 and May 31, 2026 — classified as 47 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A TKR SURGERY, WHILE ATTEMPTING TO IMPLANT THE INSERT INTO THE TIBIAL COMPONENT, ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 11MM FAILED TO LOCK PROPERLY INTO THE TIBIAL TRAY AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25343045 ↗
• InjuryMay 1, 2026Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY, THAT HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A BROKEN POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXPLANTED. THE CURRENT HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25061965 ↗
• InjuryApr 27, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA, HAD BEEN PERFORMED IN 2013, PATIENT EXPERIENCED BROKEN PS POST. THIS ADVERSE EVENT WAS ADDRESSED, BY PERFORMING REVISION SURGERY ON (B)(6) 2026, DURING WHICH, THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED. PATIENT CURRENT CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25001846 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON AN UNKNOWN DATE, THE PATIENT HAD TO UNDERGO A BURSECTOMY ON (B)(6) 2026 AND A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED. THE OUTCOME AND CURRENT STATUS OF THE PATIENT ARE UNKNOWN.

  Patient problems: Bursitis

  MAUDE report 24859279 ↗
• InjuryMay 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2015, THE POST OF ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 11MM BROKE OFF THE INSERT BASE. THE PATIENT DID NOT HAVE ANY ISSUE UNTIL MARCH THIS YEAR WHEN HE REPORTEDLY SAT DOWN AND CROSSED HIS RIGHT LEG OVER HIS LEFT TO REMOVE HIS SHOE. HE EXTERNALLY ROTATED HIS LEG WHILE PULLING HIS SHOE OFF AND HEARD A CRACKING SOUND. ON THE OPERATING TABLE, HIS KNEE WAS UNSTABLE IN THE A/P PLANE. ON OPENING THE KNEE, THE BROKEN POST WAS SITTING IN FRONT OF THE FEMORAL COMPONENT ON THE TIBIAL INSERT BASE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A NEW SIZE 5-6 13MM PS HF INSERT WAS IMPLANTED. THE OTHER COMPONENTS IN SITU WERE: SIZE 7 OXINIUM PS LEGION FEMUR, SIZE 6 TIBIAL BASEPLATE, AND A 35MM OVAL PATELLA. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21981530 ↗
• InjuryOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA REVISION WAS PERFORMED ON (B)(6)2024, THE PATIENT EXPERIENCED ANOTHER DISASSOCIATION OF THEIR LGN PS HIGH FLEX XLPE SZ 5-6 11MM. DUE TO THIS THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6)2024 TO EXCHANGE THE DISASSOCIATED INSERT FOR A DISHED INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20478107 ↗
• InjuryOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A DISASSOCIATION OF THEIR LGN PS HIGH FLEX XLPE SZ 5-6 11MM. DUE TO THIS THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024 TO EXCHANGE THE DISASSOCIATED INSERT. PATIENT EXPERIENCED ANOTHER DISSOCIATION AND WAS REVISED ON (B)(6) 2024.

  Patient problems: Joint Dislocation

  MAUDE report 20478103 ↗
• InjurySep 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED ON (B)(6) 2017, IN (B)(6) 2024, THE PATIENT REPORTED AN ACUTE ONSET OF INSTABILITY WHILE HE WAS ON HIS KNEES IN DEEP FLEXION IN A ROOF CAVITY CONDUCTING A BUILDING INSPECTION. THE SURGEON EXAMINED THE PATIENT AND THE INSTABILITY WAS NOTED, SUSPECTED FAILURE OF PS POST. A REVISION SURGERY WAS BOOKED TO INVESTIGATE SAME AND SURGERY WAS PERFORMED ON (B)(6) 2024. WHEN THE KNEE WAS OPENED TO INSPECT THE IMPLANT, IT WAS FOUND THAT THE POST HAD COMPLETELY BROKEN OFF THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM. THE INSERT WAS REPLACED WITH ANOTHER PRODUCT OF THE SAME REFERENCE NUMBER. THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. SPECIMENS WERE TAKEN TO EXAMINE IF POLY TRACES CAN BE FOUND IN THE SURROUNDING TISSUE. THE CURRENT HEALTH STATUS OF THE PATIENT IS GOOD.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20190512 ↗
• InjuryJul 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED A CRACK (THE POLY POST GIVING WAY) AND THEN FELT THEIR KNEE WAS UNSTABLE THE KNEE UNSTABLE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH A FRACTURE LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS FOUND. IT REMOVED AND EXCHANGED FOR A NEW INSERT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 19812373 ↗
• InjuryMay 27, 2024Adverse 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) 2020, THE PATIENT EXPERIENCED STIFFNESS IN THE KNEE AND FIXED FLEXION DEFORMITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT IN WHICH THE POLY WAS EXCHANGED TO A 9MM. THE KNEE WAS THEN ABLE TO EXTEND TO VISIBLE FULL EXTENSION.

  Patient problems: Deformity/ Disfigurement; Loss of Range of Motion

  MAUDE report 19400821 ↗
• InjuryJan 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED DUE TO FRACTURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 18614352 ↗
• InjuryJan 22, 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 INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 18553358 ↗
• InjuryDec 27, 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 ON (B)(6) 2012, THE PATIENT EXPERIENCED INSTABILITY AND PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16050247 ↗
• InjuryDec 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A LGN PS HIGH FLEX XLPE SZ 5-6 11MM CAM BROKE. A REVISION SURGERY WAS PERFORMED IN ORDER TO EXCHANGED THE BROKEN INSERT. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15974817 ↗
• InjuryOct 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY PERFORMED ON (B)(6) 2022, THE 11 5-6 PS HIFLEX POLY WAS REMOVED DUE TO UNSTABLE KNEE SYSTEM, THEREFORE IT WAS EXCHANGED BY A 21 5-6 CONSTRAINED POLY. THE PATELLA WAS REMOVED SURGEON THOUGHT IT WAS TO THICK, AND A 29MM RESURFACING PATELLA WAS CEMENTED IN. PATIENT WAS STABLE ON TABLE.

  Patient problems: Joint Laxity

  MAUDE report 15656514 ↗
• InjuryOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON 2012, ONE (1) LGN PS HIGH FLEX XLPE SZ 5-6 11MM BROKE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED. NO DELAY REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15626136 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA SURGERY PERFORMED ABOUT 10-15 YEARS AGO, THE PATIENT WENT THROUGH A REVISION SURGERY ON (B)(6) 2022 PER STANDARD PRACTICE. FURTHER INFORMATION IS UNKNOWN AND IS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15535499 ↗
• InjuryAug 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 ON (B)(6) 2018, THE PATIENT EXPERIENCED ONGOING PAIN AND LAXITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A LGN PS HIGH FLEX XLPE SZ 5-6 11 MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 15316363 ↗
• InjuryFeb 21, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT STARTED EXPERIENCING PAIN. THERE IS NOT ANY REPORT OF AN ASSOCIATED TRAUMA. A REVISION SURGERY WAS MADE ON (B)(6) 2021 TO EXPLANT THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM INSERT. UPON INSPECTION, THE INSERT LOOKED PITTED AND OXIDIZED. CURRENT HEALTH STATUS IS ALSO UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 13572393 ↗
• InjuryJan 18, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISCOMFORT THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022. A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS REPLACED WITH A NEW ONE, SINCE IT WAS DETERMINED TO BE BROKEN (A SCOPE WAS PERFORMED TO CONFIRM THAT THE POLY WAS DAMAGED. POLY WAS THEN REMOVED USING OSTEOTOMES AND TWEEZERS). THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 13281434 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SECOND TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, PATIENT HAD AN INFECTION OF THE KNEE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13111243 ↗
• InjurySep 14, 2021Adverse 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 UNSPECIFIED DATE, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT; THE GII OXIN P/S FEM RIGHT SZ 6 , GNS II CMT TIB SIZE 5 RIGHT , LGN PS HIGH FLEX XLPE SZ 5-6 11MM AND GNS II RESURF PAT 35MM WERE EXPLANTED. SURGEON STATED THAT THERE APPEARS TO BE NO ISSUE RELATED TO THE IMPLANTS, AS X-RAYS EXAMINATION SHOWED PROPER FIXATION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 12471974 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY OF THE JOINT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT; THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PROSTHESIS. SURGEON STATED THAT THERE IS NO FAULT RELATED TO THE LGN PS HIGH FLEX XLPE SZ 5-6 11MM ORIGINALLY IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12410961 ↗
• InjuryJul 2, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA ON 2016, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO LOOSENIN. A GNS II CMT TIB SIZE 5 LEFT AND A LGN PS HIGH FLEX XLPE SZ 5-6 11MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 12112006 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT STEPPED OUT OF HIS TRUCK AND SLIPPED ON A WRENCH WHICH LATER DISCOVERED HE HAD BROKEN THE POST IN HIS LEGION GEN II PSHF 11MM XLPE INSERT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE INSERT. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11688977 ↗

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-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
• 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