LEGION 71453232Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00885556035153), received between Jan 29, 2018 and Jul 14, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (14 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED WOUND OOZE SUGGESTIVE OF A POSSIBLE INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION TKR SURGERY ON (B)(6) 2026, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED FOR A SIMILAR S+N BACK-UP PRODUCT. A KNEE WASHOUT WAS ALSO PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 25810616 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026 IN WHICH A WASHOUT OUT WAS PERFORMED AND A LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED. THE PATIENT IS CURRENTLY BEING TREATED WITH INTRAVENOUS ANTIBIOTICS AND WASHOUTS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24924169 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24789611 ↗
• InjuryMar 13, 2026Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED THE FRACTURE OF THE POST OF AN IMPLANT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED. CASE PROCEEDED UNEVENTFULLY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; Subluxation

  MAUDE report 24590621 ↗
• InjuryJul 30, 2025Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED A BROKEN POST. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 22671196 ↗
• InjuryJun 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED DISSATISFACTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE SURGEON DISCOVERED THAT THE POST OF THE PS INSERT BROKE AT THE BASE. THEREFORE, ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXPLANTED AND REPLACED WITH A COMPONENT OF THE SAME PART NUMBER. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 22303713 ↗
• InjuryApr 20, 2025Break; Break

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT FELT HIS KNEE GIVEAWAY WHILE DOING SOME GARDENING ACTIVITIES. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH SURGEON ACCESSED PATIENT AND CONCLUDED THAT THE POST OF THE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM HAD BROKEN ON THE (1) GNS II CMT TIB SIZE 5 {} LEFT. SURGEON ELECTED TO REVISE THE INSERT AND PUT IN A NEW ONE. ADDITIONALLY, WHEN REMOVING THE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM, IT WAS BROKEN. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 21870352 ↗
• InjuryMar 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED THE BREAKAGE OF THE INSERT POST. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21506470 ↗
• InjuryNov 14, 2024Break; Break

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED 10 YEARS AGO, THE POST OF THE PATIENT'S IMPLANT BROKE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXPLANTED, AND A DISHED POLY WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20682560 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY PERFORMED ON (B)(6) 2017 DUE TO INFECTION. THE PATIENT FELT A SHARP CRACK ON (B)(6) 2024 WHILE KNEELING ON THE RIGHT KNEE, WHICH WAS PRECEDED BY 6 MONTHS OF VMO PAIN. THE PATIENT ALSO EXPERIENCES TEMPORARY LOCKING AND ANTERIOR/ANTEROLATERAL PAIN. PATIENT IS NOW HAVING RECURRENT UNPREDICTABLE INSTABILITY EPISODES WITH SHARP PAIN AND CLUNKING, AND REQUIRES ONE CRUTCH TO WALK. IT WAS REPORTED THAT THERE IS AN INCREASED AP LAXITY BUT STILL A HARD END-POINT NOTICED AFTER POSTERIOR DRAWER TESTING. THE COLLATERALS WERE REPORTED AS INTACT. A REVISION SURGERY IS BOOKED FOR (B)(6) 2024 FOR INVESTIGATION AND REVISION OF ANY DAMAGED OR LOOSE COMPONENTS. THIS ADVERSE EVENT IS STILL ONGOING.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 20201293 ↗
• InjuryAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED IN 2014, THE POST ON AN LGN PS HIGH FLEX XLPE SZ 7-8 11MM IMPLANT BROKE OFF. TO ADDRESS THIS ADVERSE EVENT, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM IMPLANT WAS EXCHANGED. FOLLOWING THE SURGERY, THE PATIENT UNDERWENT 6 WEEKS OF JOINT REHABILITATION AND EXPERIENCED REGULAR POSTOPERATIVE PAIN. THE CURRENT HEALTH STATUS SHOWS RECOVERY AND RETURN TO NORMAL ACTIVITY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19932952 ↗
• InjuryMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED 13 YEARS AGO, THE PATIENT KNEW FELT THE KNEE WAS BECOMING LESS AND LESS STABLE UNTIL IT BECAME COMPLETELY UNSTABLE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AND IT WAS NOTICED THAT THE POST ON ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 11MM SNAPPED OFF AND IT WAS IN TWO PIECES INSITU. THIS ADVERSE EVENT WAS SOLVED BY REMOVING AND REPLACING THE DEVICE. AFTER DAY 10 POST-OP, PATIENT IS RECOVERING WELL.

  Patient problems: Failure of Implant

  MAUDE report 18927235 ↗
• InjuryNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED PAIN. AS A RESULT OF THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A BROKEN LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Pain

  MAUDE report 18141479 ↗
• InjuryOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT BROKE THE POST OF THE LGN PS HIGH FLEX XLPE SZ 7-8 13, APPROXIMATELY IN (B)(6) 2023. THE BREAKAGE OCCURRED DUE TO "NORMAL WEAR", THE PATIENT DID NOT HAVE TRAUMA TO THE KNEE THAT CAUSED IT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, WHERE THE INSERT WAS EXPLANTED AND REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17966237 ↗
• 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 11MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16644536 ↗
• InjuryDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED IN 2014, A REVISION SURGERY WAS NECESSARY DUE TO KNEE INSTABILITY. THEREFORE, A POLYETHYLENE INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2022 AND IT WAS NOTICED THAT THE POST OF THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM HAD BROKE OFF. CURRENT HEALTH STATUS OF PATIENT IS FINE.

  Patient problems: Failure of Implant

  MAUDE report 16048745 ↗
• InjurySep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED THE BREAKAGE OF A POST OF THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND THE DEVICE WAS EXPLANTED. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15426483 ↗
• InjuryAug 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2013, ON (B)(6) 2022 THE POST BROKE OFF THE LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 7-8 11MM. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE INSERT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15307960 ↗
• InjuryJul 19, 2022Break; Break

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM WAS FOUND TO HAVE A BROKEN POST. 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 15060161 ↗
• InjuryMay 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT HAD A FALL CAUSING THE POST TO FRACTURE. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14438557 ↗
• InjuryNov 7, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, A REVISION SURGERY HAD TO BE PERFORMED. A LEGION PS HIGH FLEX XLPE SIZE 7-8 11MM POLY WAS EXCHANGED. THE POLY EXPLANTED APPEARS TO HAVE A WARPED POST. CURRENT PATIENT HEALTH STATUS REMAINS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12763419 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKR SURGERY, HAD BEEN PERFORMED ON 2016, ONE LGN PS HIGH FLEX XLPE SZ 7-8 11MM AND ONE 35MM RESURFACING PATELLA APPEAR TO TRIGGER PAIN AND AVASCULAR NECROSIS (AVN). THE PROBLEM WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, WHERE AN 7/8 12MM HIGH FLEX WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Necrosis; Pain

  MAUDE report 12573140 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKR, PATIENT SUFFERED SOME TRAUMA ON THE KNEE TREATED. REVISION SURGERY WAS PERFORMED ON MARCH 4TH, AFTER VERIFYING BY ARTHROSCOPY THAT THE PS POST HAD SNAPPED. BROKEN LEGION PS HIGH FLEX XLPE SIZE 7-8 11MM WAS REPLACED WITH A 7-8 13MM POLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587184 ↗
• MalfunctionMar 3, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE INSERT WOULD NOT LOCK INTO TIBIA TRAY. A BACKUP ITEM WAS OPENED AND SEATED CORRECTLY. INSTRUMENTS WERE INSIDE THE PATIENT. THERE WAS NO DELAY OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403057 ↗
• InjuryFeb 15, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, IT HAS BEEN MADE A REVISION SURGERY DUE TO TIBIAL LOOSENING. THE LGN PS HIGH FLEX XLPE SZ 7-8 11MM, GNS II NON-POR TIB SZ 7 RIGHT AND LEGION PS OXIN FEM SZ7 RT WERE EXPLANTED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11326536 ↗

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-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