LEGION 71453212Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00885556034170), received between Mar 31, 2017 and Jun 29, 2026 — classified as 43 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY AND PATELLOFEMORAL PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE POLYETHYLENE TIBIAL INSERT WAS EXCHANGED AND REVISION OF THE PATELLA WAS PERFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 25661824 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON UNKNOWN DATE, PATIENT EXPERIENCED MULTIPLE FALLS ON THE OPERATED KNEE, ALSO, THE KNEE STARTED TO SWELL, AND HAD LIMITED RANGE OF MOTION. THIS ADVERSE EVENT WAS SOLVED BY A TKA REVISION SURGERY PERFORMED ON (B)(6) 2026 INVOLVING JOINT WASHOUT, SYNOVECTOMY, AND REPLACEMENT OF ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 11MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fall; Loss of Range of Motion; Swelling/ Edema; Synovitis

  MAUDE report 24724908 ↗
• InjuryFeb 9, 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 INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS CHANGED FOR A LARGER IMPLANT. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24293415 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR DAYS AFTER A TKA THAT TOOK PLACE ON (B)(6) 2025, THE INCISION RIPPED OPEN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DURING WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS REPLACED WHILE REPAIRING THE INCISION. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Wound Dehiscence

  MAUDE report 22806808 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL RIGHT KNEE ARTHROPLASTY SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED KNEE INFECTION AND ATRAUMATIC RIGHT KNEE PAIN FOR SEVEN DAYS. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A DAIR ON (B)(6) 2025, IN WHICH A LEGION PS HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGE AS PART OF WASHOUT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Implant Pain; Medical device site infection

  MAUDE report 21939445 ↗
• InjuryMar 18, 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 AN UNKNOWN DATE, PATIENT EXPERIENCED A PATELLA RESURFACING. THIS ADVERSE EVENT WAS ADDRESSED ON (B)(6) 2025, DURING WHICH SURGEON EXCHANGED THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630543 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2023, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2025 DUE TO A FALL THAT LEAD TO DAMAGE TO THE SURROUNDING LIGAMENTS, WHICH CAUSED STABILITY ISSUES. A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS EXTRACTED AND REPLACED WITH A CONSTRAINED POLY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Damage to Ligament(s); Fall

  MAUDE report 21595432 ↗
• InjuryNov 18, 2023Adverse 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 TREATED WITH A SYNOVECTOMY, WASHING OF THE JOINT, AND REVISION SURGERY THAT WERE PERFORMED ON (B)(6) 2023, IN WHICH A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18166935 ↗
• InjuryAug 4, 2023Adverse 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) 2022, THE PATIENT COMPLAINED OF INSTABILITY ISSUES. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A POLY SWAP SURGERY ON (B)(6) 2023. THE PATIENT LEFT SURGERY IN GOOD HEALTH. PATIENT´S CURRENT HEALTH IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17466801 ↗
• MalfunctionJun 12, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, AFTER A TKA SURGERY DONE 12 YEARS AGO, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 DUE TO UNCLEAR CIRCUMSTANCES. DURING THIS REVISION, A GII PS HI FLEX ISRT SZ 3-4 9 WAS EXPLANTED. FOR THE INSERT REPLACEMENT, A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS UNABLE TO BE LOCKED. THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS REMOVED, THE RAIL ON THE TRAY AND INSERT WERE INSPECTED, THEN IT WAS UNABLE TO BE INSERTED. A TTT PROCEDURE WAS PERFORMED FOR FULL ACCESS TO THE SIDE OF THE TRAY, AND FINALLY, THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS USED WITH A SMALL AMOUNT OF "DEPUY CMW2" CEMENT AT THE FRONT OF THE TRAY TO LOCK THE REPLACEMENT INSERT. ALL THE INSERTS AND THE TIBIAL TRAY HAD BEEN CHECKED FOR DEFECTS MULTIPLE TIMES AND NONE WERE FOUND. A DELAY OF APPROXIMATELY 1 HOUR TO THE SURGERY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114129 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA SURGERY ON (B)(6) 2013, A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON (B)(6) 2022. ONLY THE LGN PS HIGH FLEX XLPE SZ 3 4 11MM WAS EXCHANGED TO A NEW ONE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 15870031 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER IMPLANTATION OF A LGN PS HIGH FLEX XLPE SZ 3-4 11MM ON (B)(6) 2022, THE PATIENT FELT UNSTABLE AFTER A DEEP KNEE FLEXION. EVENT WILL BE TREATED WITH A REVISION SURGERY. 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 15869016 ↗
• InjuryAug 24, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AND COMPLAINED OF A LIMITED RANGE OF MOTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS EXCHANGED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 15287977 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO INFECTION, WHERE THE LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 3-4 11 MM WAS EXCHANGED. CURRENT HEALTH STATUS 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: Unspecified Infection

  MAUDE report 15242513 ↗
• InjuryJul 30, 2022Adverse 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) 2022, THE PATIENT FELT A POP AND HAD A LOT OF PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM, WHICH WAS FOUND TO BE DISLODGED OUT THE FRONT OF THE KNEE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15136781 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKR, PATIENT HAD A "HEAVY FALL" AND NOTED THAT SOMETHING POPPED WITH SUBSEQUENT GRINDING SOUND AND LOSS OF MOVEMENT/MOTION OF KNEE. A REVISION SURGERY WAS PERFORMED AND LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS NOTICED TO BE COMPLETELY DISSOCIATED. A WASH OUT WAS PERFORMED AND INSERT WAS UPSIZED FROM 11MM TO 15MM THICKNESS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 14638522 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2017 USING OXINIM TECHNOLOGY BY SMITH & NEPHEW, THE PATIENT HAS HAD PAIN AND HAS BEEN LIMPING FOR OVER A YEAR. IT WAS NOTICED ON A BONE SCAN THAT THE JOINT IS LOOSE AS THE CEMENT DID NOT STICK. REVISION SURGERY WILL BE PERFORMED ON (B)(6), 2022.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Implant Pain; Inadequate Pain Relief; Joint Laxity; Subluxation

  MAUDE report 14176241 ↗
• InjuryApr 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA IN 2016 (UNKNOWN DAY AND MONTH) A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE IMPLANTS DUE TO PERIPROSTHETIC INFECTION. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14068189 ↗
• InjuryApr 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY IN KNEE. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14061323 ↗
• InjuryFeb 9, 2022Adverse 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 UNDERWENT A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS REMOVED AND REPLACED WITH LEGION REVISION. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13502038 ↗
• InjuryJan 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, ON (B)(6) 202 AN X-RAY FOUND THAT THE LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE SIZE 3-4 11MM WAS OUT OF POSITION. A REVISION SURGERY WAS PERFORMED TO REPLACE THE DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13205940 ↗
• InjuryDec 28, 2021Adverse 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) 2018, THE PATIENT HAD EXPERIENCED KNEE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO SOLVE THIS ADVERSE EVENT. IT WAS DECIDED TO REMOVE THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM. THE SCAR TISSUE AND SOME OSTEOPHYTE TISSUE WAS CLEARED, FLEXION AND EXTENSION SPACES PRESSURE WERE CHECKED WITH VERASENSE TOOL WHICH SHOWED TO BE NORMAL. SURGEON UPSIZED POLY TO 13MM CONSTRAINED INSERT AS IT FELT MORE STABLE. THE WOUND WAS CLOSED IN LAYERS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13094721 ↗
• InjuryDec 14, 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 AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 11MM WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 13002683 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED TIBIAL COLLAPSE AND FEMUR LOOSENING DUE TO AN INFECTION THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021, IN WHICH THREE (3) COMPONENTS, A GII NONPOROUS PS FEM SZ 4 RT, A GNS II CMT TIB SIZE 3 RIGHT AND A LGN PS HIGH FLEX XLPE SZ 3-4 11MM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12560911 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING TKA SURGERY, A LEGION PS HIGH FLEX XLPE SIZE 3-4 11MM DID NOT MATCH WITH THE BASEPLATE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE OF THE SAME SIZE. IT IS UNKNOWN IF THIS CAUSED ANY DELAY IN THE SURGERY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038857 ↗

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