LEGION 71453177Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556487143), received between Feb 10, 2020 and Mar 7, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2026Adverse 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 INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH AN I&D POLY EXCHANGE WAS PERFORMED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24541644 ↗
• InjuryMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY/HAD BEEN PERFORMED ON (B)(6) 2017 THE PATIENT EXPERIENCED A FALL ON 2024 AND SINCE THEN HAS HAD ONGOING PAIN, CLUNKING AND INSTABILITY. SUSPECTED POST BROKEN ON ONE (1)LGN PS HIGH FLEX XLPE SZ 7-8 10MM. THIS ADVERSE EVENT WAS SOLVED A REVISION SURGERY ON (B)(6) 2025, IN WHICH DR PARKER INITIALLY PERFORMED AN ARTHROSCOPY AND DISCOVERED THAT THE POST OF POLY INSERT HAD BROKEN. FROM THERE HE PERFORMED AN ARTHROTOMY + POLY EXCHANGE TO REPLACE THE POLY WITH A NEW ONE. CURRENT HEALTH STATUS OF PATIENT IS GOOD.

  Patient problems: Discomfort; Failure of Implant; Fall; Implant Pain; Joint Laxity; Pain

  MAUDE report 22024699 ↗
• InjuryDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT KNEE KEPT DISLOCATING IN DEEP FLEXION AND RELOCATED IN EXTENSION. THE SURGEON ALSO REPORTED THAT PATIENT HAD A FALL WITHIN FIRST 2 WEEKS OF PRIMARY SURGERY IN 2023 AND FRACTURED PATELLA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN ORDER TO EXCHANGE LGN PS HIGH FLEX XLPE SZ 7-8 10MM. UPON REMOVAL OF PRIMARY INSERT, IT WAS FOUND THAT THE POST WAS BROKEN OFF FROM THE BODY OF THE INSERT. POST FRAGMENT WAS LOCATED POSTERIORLY TO FEMORAL COMPONENT BY SURGEON AND REMOVED FROM PATIENT. SURGEON ADVISES THAT INSERT POST FRACTURE MOST LIKELY OCCURRED WHEN THE PATIENT FELL IN 2023. A NEW GNS II CON INS SZ7-8 13MM WAS IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Fall

  MAUDE report 20976837 ↗
• InjuryNov 13, 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) 2023, PATIENT EXPERIENCED ISSUES WITH SOFT TISSUE BALANCING. THIS WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH, THE LGN PS HIGH FLEX XLPE SZ 7-8 10MM AND LEGION PS OXIN FEM SZ8 RT, WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20674284 ↗
• InjuryAug 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED AROUND (13) THIRTEEN YEARS AGO, THE PATIENT COMPLAINED OF 'CLUNKING' WHEN GETTING OUT OF A CHAIR. SURGEON FOUND THAT THE POST OF THE LGN PS HIGH FLEX XLPE SZ 7-8 10MM HAD BROKEN. THIS WAS TREATED VIA REVISION SURGERY ON (B)(6) 2023, IN WHICH A LGN PS HIGH FLEX XLPE SZ 7-8 10MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 17633667 ↗
• InjuryMay 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED IN 2015, THE PATIENT EXPERIENCED POST BREAKAGE (LEGION PS HIGH FLEX XLPE SIZE 7-8 10MM) AFTER JUMPING DOWN FROM A TRUCK. THIS EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH AN IDENTICAL INSERT WAS PLACED IN EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16927090 ↗
• InjuryNov 22, 2021Adverse 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 (B)(6) 2019 TO TREAT OSTEOARTHRITIS, THE PATIENT EXPERIENCED A DECREASED RANGE OF MOTION ON AN UNSPECIFIED DATE DESPITE OF BEING COMPLIANT WITH POST-OP PROTOCOLS. A MANIPULATION UNDER ANESTHETIC WAS PERFORMED ON AN UNSPECIFIED DATE, BUT IT WAS NOT SUCCESSFUL AND THE PATIENT CONTINUED TO HAVE A LIMITED RANGE OF MOTION. AFTER THAT, ON AN UNSPECIFIED DATE, THE PHYSICIAN PERFORMED AN ARTHROSCOPIC SYNOVECTOMY AND THE RANGE OF MOTION RETURNED. LATER ON, THE PATIENT WAS DIAGNOSED WITH BOWEL CANCER SOON AFTER, AND THE RANGE OF MOTION DECREASED FROM 30 DEGREE TO 80 DEGREES. ON 04-NOV-2021 THE PHYSICIAN PERFORMED A RADICAL OPEN SYNOVECTOMY TO DECREASE THE INSERT THICKNESS FROM 10 MM TO 9 MM. INTRAOPERATIVELY, IT WAS NOTICED SIGNIFICANT SCARE TISSUE. THERE IS NOT ANY INDICATION THAT THE CONDITION PERSISTS AFTER THE LAST PROCEDURE.

  Patient problems: Loss of Range of Motion; Scar Tissue; Synovitis

  MAUDE report 12857270 ↗
• InjuryJul 9, 2021Adverse 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) 2018 AT THE (B)(6) HOSPITAL THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY AN EXCHANGE OF THE LEGION PS HIGH FLEX XLPE SIZE 7-8 10MM ,PATELLA WAS LOSE AND REVISED ON (B)(6) 2021 ON THE (B)(6) HOSPITAL. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 12144750 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENT HAD HAD MULTI LIGAMENT RECONSTRUCTION, BONE STAPLES IN BOTH LATERAL TIBIA AND PROXIMAL FEMUR MEDIAL. THESE STAPLES WERE STILL INSIDE AT TIME OF REVISION SURGERY (B)(6) 2020. REVISION SURGERY OF TIBIAL BASE PLATE, INSERT AND PATELLA RESURFACING. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 10906556 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE REPLACEMENT FOR THE KNEE THAT WAS ¿GIVING WAY¿ AND SUBLUXING PATELLA. THE SURGEON EXCHANGED THE TIBIAL INSERT TO A THICKER ONE AND LATERAL RELEASE PERFORMED. THE KNEE WAS ASSESSED AS CLINICALLY STABLE AT THE COMPLETION OF THE OPERATION BY THE SURGEON.

  Patient problems: Injury

  MAUDE report 9687642 ↗

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-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-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-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-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