LEGION 71453211Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00885556035252), received between Jun 21, 2017 and Jul 21, 2026 — classified as 52 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 64 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED IN 2022, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY TKA REVISION SURGERY ON (B)(6) 2026, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGED AND THE KNEE HAD A WASHOUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 25899359 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY/TREATMENT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGE AFTER WASHOUT. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23631489 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON A CURRENTLY UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL AND HAD A STITCH ABSCESS. THE SURGEON NOTICED THAT THE INFECTION WENT INTO THE JOINT CAPSULE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE SURGEON DECIDED TO WASHOUT THE JOINT OUT. THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGED AND REPLACED WITH ONE OF THE SAME SIZE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Abscess; Fall; Medical device site infection

  MAUDE report 23532126 ↗
• InjuryMay 12, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED SCARS AND LIMITED MOTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE (1) LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS REPLACED WITH A NEW 3-4 10 MM PS LEGION POLY. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 22003048 ↗
• InjuryOct 23, 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 DOCTOR OBSERVED ELEVATED INFLAMMATION LEVELS IN THE PATIENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY IN (B)(6) 2023, IN WHICH THE LINER WAS REPLACED WITH A DIFFERENT S+N PRODUCT. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 20515944 ↗
• MalfunctionDec 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA SURGERY, IT WAS NOTICED THAT THE PACKAGING OF A LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS BROKEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH 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 18251596 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER A TKA, THE PATIENT PRESENTED AN INFECTION. THIS WAS TREATMENT WITH A REVISION SURGERY AND A WASHOUT THAT TOOK PLACE ON (B)(6) 2023. IN THIS REVISION SURGERY, THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS EXPLANTED AND REPLACED WITH ANOTHER SMITH AND NEPHEW DEVICE. AT THIS TIME, PATIENT STATUS IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 17958760 ↗
• MalfunctionSep 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING TKA SURGERY, A LGN PS HIGH FLEX XLPE SZ 3-4 9MM COULD NOT BE STUCK SMOOTHLY AND ALWAYS SLIPPED FORWARD. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 17683473 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA WAS PERFORMED ON (B)(6) 2022, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2022 TO REPLACE THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM DUE TO INFECTION AND INFLAMMATORY REACTION.

  Patient problems: Inflammation; Unspecified Infection; Wound Dehiscence

  MAUDE report 17257758 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION SURGERY OF THE RIGHT KNEE ON (B)(6)2023 DUE TO INSTABILITY (HYPEREXTENSION). DURING THE PROCEDURE THE 9MM INSERT AND EXPLANTED AND REPLACED WITH AN 11MM INSERT. THE PATIENT KEPT EXPERIENCING INSTABILITY EVEN AFTER THIS INTERVENTION. THE PRIMARY RIGHT KNEE SURGERY WAS PERFORMED ON (B)(6) 2022; AND THE FIRST REVISION SURGERY OF THE KNEE WAS PERFORMED ON (B)(6)2022 DUE TO AN INFECTION (COVERED UNDER CASE-(B)(4).

  Patient problems: Hyperextension; Joint Laxity; Subluxation

  MAUDE report 17163898 ↗
• InjuryJun 12, 2023Migration; Migration

  IT WAS REPORTED THAT, A LGN PS HIGH FLEX XLPE SZ 3-4 9MM ORIGINALLY IMPLANTED ON (B)(6) 2023, HAD TO BE REVISED ON (B)(6) 2023, AS IT HAD BECOME DISENGAGED FROM THE TIBIAL BASEPLATE. THIS LED TO THE FEMORAL COMPONENT WEARING ON THE METAL TIBIAL COMPONENT, LEAVING METAL DEBRIS IN THE JOINT. THE JOINT WAS WASHED OUT AND DEBRIDED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE INSPECTED WITH SOME VISIBLE DAMAGE TO THE FEMORAL ARTICULAR SURFACE. THE DECISION WAS MADE TO LEAVE THEM INSITU, AS THEY WERE EXTREMELY WELL CEMENTED AND THE POTENTIAL DAMAGE DONE REMOVING THEM OUTWEIGHED ANY BENEFIT OF REPLACING THEM. THE PATIENT'S BMI MADE THE CASE EXTREMELY DIFFICULT, AND IT IS BELIEVED, THIS MAY HAVE CONTRIBUTED TO THE POLY INSERT POTENTIALLY NOT BEING LOCKED IN PROPERLY AT TIME OF THE PRIMARY SURGERY. THE PATIENT WAS DISCHARGED AND RECOVERING WELL, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Metal Related Pathology; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113957 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INSTABILITY AND PAIN IN KNEE. SURGEON STATED TO BELIEVE THAT THE PAIN WAS MAINLY DUE TO THE PATIENT´S CEREBRAL PALSY DIAGNOSIS. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS REPLACED TO HELP WITH STABILITY AND THE GII OVAL RESURFACING PAT 29MM WAS REPLACED TO HELP WITH THE PATELLOFEMORAL JOINT PAIN. THE PATIENT LEFT SURGERY IN GOOD HEALTH. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 17089558 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2022, THE PATIENT FELL OFF A CHAIR AND DISLOCATED THE KNEE ON (B)(6) 2023. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM FOR A CONSTRAINED INSERT IN ORDER TO GIVE THE KNEE EXTRA STABILITY. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16505741 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2019, PATIENT PRESENTED WITH DISCOMFORT CAUSED BY PATELLA MAL-TRACKING. THIS WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022 TO RELIEVE SOME LATERAL PATELLA LIGAMENTS TO ALLOW MORE IDEAL PATELLA TRACKING, SURGEON WISHED TO EXCHANGE THE LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 3-4 9MM, THERE WAS NO WEAR ON THE EXPLANTED INSERT, AND ALL OTHER PROSTHESIS LOOKED GOOD. CURRENT HEALTH STATUS OF THE PATIENT IS RECOVERED AND WELL.

  Patient problems: Discomfort

  MAUDE report 15708789 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE REPLACEMENT ON THE LEFT KNEE HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT NEVER STOPPED HAVING PAIN AND SWELLING; DIFFICULTY WALKING AND SITTING FOR A LONG TIME; PROBLEMS GOING UP AND DOWN STAIRS, KNEELING AND REMAINING STOOD UP FOR PERIODS OF ONE HOUR. THE PAIN IS CONSTANT AND DIFFICULTING DAILY ACTIVITIES. THE PATIENT ALSO WALKS WITH A LIMP AS THE RIGHT LEG IS SHORTER THAN THE LEFT. PATIENT HAS CONTINUED PHYSICAL THERAPY, BUT THERE HAS NOT BEEN ANY CHANGE AND THE KNEE IS NOT IMPROVING. PATIENT ALSO HAD MANIPULATION UNDER ANESTHESIA AT SOME POINT AFTER THE KNEE REPLACEMENT. THE SITUATION IS ONGOING. THE PATIENT IS BILATERAL: THE RIGHT PROSTHETIC KNEE WAS IMPLANTED ON 2022.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Swelling/ Edema; Unequal Limb Length

  MAUDE report 15591238 ↗
• InjuryJul 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2022, IT WAS FOUND THAT THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM WAS NOT LOCKED IN THE TIBIA TRAY. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15117430 ↗
• MalfunctionMay 31, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING SURGERY, A LGN PS HIGH FLEX XLPE SZ 3-4 9MM WOULD NOT LOCK ONTO BASE PLATE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS GREATER THAN 30-MINS DELAYED. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545509 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE INSERT WAS DISLOCATED WHILE THE PATIENT WAS ON REHABILITATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12410816 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT, AFTER A LEFT TKA PERFORMED ON (B)(6) 2018, THE PLAINTIFF EXPERIENCED A TRAUMATIC FALL, WHICH LED TO PAIN AND INSTABILITY. X-RAYS SUGGEST THAT THE LINER IS ANTERIOR TO THE TIBIAL BASEPLATE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. THE LINER WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12388804 ↗
• MalfunctionJul 5, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A TKA THE LEGION PS HIGH FLEX XLPE SIZE 3-4 9MM WILL NOT SEAT ON THE BASEPLATE. SURGERY CONTINUED WITH A BACK UP DEVICE, NO DELAY REPORTED. PATIENT WAS NOT HARMED AS A CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119204 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA AND AS PART OF AN I&D PROCEDURE, THE LGN PS HIGH FLEX XLPE SZ 3-4 9MM (IMPLANTED ON AN UNKNOWN DATE) WAS REMOVED AND REPLACED WITH #71420524 (20AT32740) ON (B)(6) 2021. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Abscess; Unspecified Musculoskeletal problem

  MAUDE report 11921701 ↗
• MalfunctionApr 6, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING RIGHT TKA SURGERY, USING THE LEGION GII SERIES, THE INSERT WAS CUT ABNORMALLY ON THE OUTSIDE AND COULD NOT BE PLACED, AND A NEW INSERT WAS USED TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617553 ↗
• InjuryFeb 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TKA, PATIENT PRESENTED JOINT INSTABILITY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE LEGION PS HIGH FLEX XLPE SZ 3-4 9MM FOR A 12MM PS HIGH FLEX XLPE POLY. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 11390992 ↗
• MalfunctionDec 15, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY, AFTER INSTALLING THE LEGION PS HIGH FLEX XLPE SIZE 3-4 9MM INSERT, IT WAS UNSTABLE IN COMBINATION WITH THE BASEPLATE. FINALLY A SAME SIZE INSERT WAS USED TO COMPLETE THE SURGERY. FURTHER DETAILS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010717 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A POLY EXCHANGE DUE TO INFECTION. THERE IS NO INFORMATION ABOUT THE ORIGINAL IMPLANTS OR SURGERY DATE. A 3-4 9MM POLY WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 10957036 ↗

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-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
• 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