LEGION 71453231Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00885556034620), received between Apr 13, 2017 and May 31, 2026 — classified as 85 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 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 88 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED WITH LEGION AND GENESIS SYSTEM ON (B)(6) 2017, THE CLINICAL SUBJECT EXPERIENCE PAIN AND DISCOMFORT AT THE LEFT KNEE. THIS ADVERSE EVENT WAS TREATED BY SURGERY PROCEDURE IN (B)(6) 2026, IN WHICH THE ADVERSE EVENT WAS ADDRESSED. THE PATIENT RECOVERED.

  Patient problems: Arthralgia

  MAUDE report 25342839 ↗
• InjuryJan 12, 2026Fracture

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT'S INSERT POST BROKE. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24050190 ↗
• InjuryJan 7, 2026Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2014. HE PATIENT EXPERIENCED SYMPTOMS OF INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 9 MM WAS EXCHANGED WITH A NEW POLYETHYLENE. INTRAOPERATIVELY NOTICED THAT THE IMPLANTED INSERT HAD A BROKEN PS POST. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23989099 ↗
• InjuryDec 4, 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) 2023, PATIENT EXPERIENCED CRACKING SOUNDS WHEN KNEELING. PATIENT HAD A RUBBER MAT UNDER HIS KNEES. AS HE WAS SLIDING AROUND, SUDDENLY FELT INTENSE PAIN IN HIS KNEE, SAW STARS, AND FELL BACKWARDS UNCONTROLLABLY, HYPEREXTENDING HIS KNEE. AFTER THAT, PATIENT COULD NOT STRAIGHTEN HIS KNEE FREELY ANYMORE. BECAUSE OF THIS ISSUE THERE WAS A 40° EXTENSION DEFICIT IN THE LEFT KNEE JOINT. IN ADDITION, THE FEMORAL PROSTHETIC LIMB WAS DISLOCATED OVER THE PEG OF THE TIBIAL INSERT. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, IN WHICH, THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXCHANGED. DURING PROCEDURE, REPOSITIONING OF THE JOINT WAS NOT POSSIBLE WITH REASONABLE FORCE WITHOUT ENDANGERING THE LIGAMENTS. THEREFORE, THE PEG OF THE TIBIAL INSERT WAS SAWN OFF. STABLE LIGAMENTOUS GUIDANCE WAS THEN RESTORED WITH REGARD TO THE COLLATERAL LIGAMENTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23715267 ↗
• InjuryOct 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED THE FRACTURE OF THE POST IN THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23218980 ↗
• InjurySep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT KNEE ARTHROTOMY PERFORMED ON AN UNSPECIFIED DATE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM THAT HAD THE INSERT PEG BROKEN AND REPLACED IT WITH EQUIVALENT INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 23084203 ↗
• InjurySep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE POST SHEARED OFF. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23061796 ↗
• InjuryJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2020, THE PATIENT PRESENTED WITH INSTABILITY IN THE LEFT KNEE AND WAS TAKEN TO A REVISION SURGERY ON (B)(6) 2025. DURING THE REVISION SURGERY, A FRACTURED POST ON ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS OBSERVED. THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXPLANTED AND CHANGED FOR A 11MM INSERT. THERE WERE A TOTAL OF EIGHT (8) PIECES OF PLASTIC RETRIEVED FROM THE PATIENT, TWO (2) LARGE PIECES AND (SIX) 6 SMALLER PIECES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 22665062 ↗
• InjuryMay 1, 2025Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT, AFTER BILATERAL KNEE REPLACEMENTS HAD BEEN PERFORMED IN 2017, THE PATIENT BEGAN EXPERIENCING ISSUES WITH HIS LEFT KNEE. AFTER FURTHER INVESTIGATION IT BECAME EVIDENT THAT THE POST ON THE PS INSERT ON THE LEFT KNEE HAD BROKEN. THIS WAS TREATED BY DR. (B)(6) ON (B)(6) 2025, IN WHICH HE PERFORMED A REVISION SURGERY (POLY EXCHANGE). PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21942726 ↗
• InjuryApr 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE POST OF A LGN PS HIGH FLEX XLPE SZ 7-8 9MM BROKE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXPLANTED AND IT WAS REPLACED WITH A SAME SIZE DEVICE. PATIENT LEFT IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21755914 ↗
• InjuryMar 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO THE POST OF ONE (1) LEGION HFPS 7-8 9MM INSERT BEING BROKEN, IN WHICH THE DEVICE WAS EXPLANTED AND EXCHAGED WITH A S+N DEVICE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 21630434 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED JOINT INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKA SURGERY ON (B)(6) 2024, IN WHICH IT WAS ELECTED TO WASHOUT THE JOINT AND CHANGE THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 20854375 ↗
• InjuryOct 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, A LGN PS HIGH FLEX XLPE SZ 7-8 9MM AND PATELLA WERE REVISED ON (B)(6) 2024. THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS REMOVED WITH POST BROKEN. THE DATE OF THE PRIMARY SURGERY IS UNKNOWN. FURTHER COMPLICATIONS WERE NOT REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20397963 ↗
• InjuryAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2013, THE PATIENT REPORTED A 'POP' IN HIS KNEE AND THEN BECAME UNSTABLE. THEREFORE A REVISION TOOK PLACE ON 08-AUG-2024, DURING SURGERY, IT WAS DISCOVERED THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM POST HAD BROKEN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20076417 ↗
• InjuryJul 26, 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) 2022, THE PATIENT NEEDED A PATELLA RESURFACING. THIS EVENT WAS HELD ON (B)(6) 2024 BY REVISION SURGERY, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXCHANGE FOR STABILITY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19844650 ↗
• InjuryMay 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) 2019, THE PATIENT EXPERIENCED KNEE STIFFNESS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024 IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 9MM WAS EXCHANGED WITH EXCISION OF SCAR TISSUE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 19399046 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2021, THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM HAD TO BE REVISED ON (B)(6) 2023 DUE TO INFECTION. THE IMPLANT WAS EXCHANGED FOR A SAME SIZE INSERT. NO OTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 18553216 ↗
• InjuryJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT PRESENTED TO SURGEON WITH SUBLUXATION IN KNEE. IT WAS DETERMINED BY THE SURGEON THAT THE POST OF THE LGN PS HIGH FLEX XLPE SZ 7-8 9MM THAT WAS ORIGINALLY IMPLANTED HAD BROKEN. A KNEE REVISION WAS PERFORMED ON (B)(6) 2023 TO REPLACE THE POLY TO A CONSTRAINED VERSION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 18466050 ↗
• InjuryDec 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED A BROKEN LGN PS HIGH FLEX XLPE SZ 7-8 9MM POST. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18336504 ↗
• InjuryNov 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED, THE PATIENT HAD TUMBLING INCIDENT, AFTER WHICH HIS KNEE FELT DIFFERENT AND VERY UNSTABLE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH THE INSERT WAS NOTICED FRACTURE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN

  Patient problems: Failure of Implant; Fall; Joint Dislocation; Joint Laxity

  MAUDE report 18131622 ↗
• InjurySep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL AND THE POST ON THE IMPLANTED LGN PS HIGH FLEX XLPE SZ 7-8 9MM BROKE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17780597 ↗
• InjuryJun 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED IN (B)(6), THE PATIENT EXPERIENCED A BREAKAGE OF THE POST OF A LGN PS HIGH FLEX XLPE INSERT. THIS WAS RESOLVED VIA A REVISION SURGERY ON (B)(6) 2023, DURING WHICH THE REPORTED DEVICE WAS EXPLANTED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17160098 ↗
• InjuryApr 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKR SURGERY PERFORMED IN AN UNSPECIFIED DATE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHERE THE SURGEON NOTICED THAT THE POST ON PS INSERT WAS BROKEN. THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792414 ↗
• 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 RIGHT KNEE ON (B)(6) 2022 DUE TO JOINT INSTABILITY AND TIBIAL POST FRACTURE OF A LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 9MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16645195 ↗
• 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) 2023 DUE TO TIBIAL POST FRACTURE OF A LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 9MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16644829 ↗

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-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
• 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