LEGION 71453202Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556034316), received between Nov 1, 2017 and Dec 26, 2022 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THERE WAS AN IMPROPER LOCKING OF THE LGN PS HIGH FLEX XLPE SZ 1-2 11MM IN TIBIAL TRAY WITH 5-6 ATTEMPTS. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE, USING SAME SIZE IMPLANT. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048660 ↗
• InjuryOct 4, 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, THE PATIENT EXPERIENCED INSTABILITY APPROXIMATELY TWO YEARS POST-OP. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 1-2 11MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15535464 ↗
• MalfunctionAug 10, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, WHEN PERFORMING A TOTAL KNEE REPLACEMENT, A LEGION PS HIGH FLEX XLPE SIZE 1-2 11MM WOULD NOT SUCCESSFULLY ENGAGE INTO THE BASEPLATE AT THE TIME OF IMPLANTATION. SURGERY WAS RESUMED WITH A SMALLER SIZE INSERT AFTER TECHNOLOGY PROCESSES, BECAUSE A BACK-UP INSERT OF THE SAME SIZE WAS NOT AVAILABLE. THIS EVENT INCREASED THE OPERATIVE DIFFICULTY AND EXTENDED DURATION BY MORE THAN 30 MINUTES. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

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

  MAUDE report 15203701 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED ON (B)(6) 2017 THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY OF THE LGN PS HIGH FLEX XLPE SZ 1-2 11MM ON (B)(6) 2022. THE DEVICE WAS NOT DEFECTIVE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13720537 ↗
• InjuryJan 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, THE LEGION PS HIGH FLEX XLPE SIZE 1-2 11MM IMPLANTED GOT OUT OF THE TIBIA BASEPLATE. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 IN ORDER TO SOLVE THIS ADVERSE EVENT. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365154 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT KNEE PAIN AND EFFUSION. THIS ADVERSE EVENT WAS TREATED BY DOING A WOUND DEBRIDEMENT ON (B)(6) 2021. DURING THE SAID PROCEDURE, THE SURGEON FOUND SIGNS OF METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO METALLOSIS AND IMPLANT LOOSENING. DURING THIS PROCEDURE, THE FEMORAL COMPONENT, INSERT AND TIBIAL COMPONENT WERE EXPLANTED FROM THE PATIENT. CURRENTLY THE PATIENT CONDITION IS STABLE AFTER REVISION SURGERY AND IS IN THE PROCESS OF RECOVERY.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 13010619 ↗
• InjuryJul 1, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA, THE LGN PS HIGH FLEX XLPE SZ 1-2 11MM COULD NOT BE SEATED TO THE BASEPLATE. A 9MM SMITH AND NEPHEW INSERT BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099747 ↗
• InjuryNov 18, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, WHEN PREFORMING A TKR, THE LEGION PS XLPE HIGH FLEXION ARTICULAR INSERT SIZE 1/2 11MM WOULD NOT SUCCESSFULLY ENGAGE INTO THE BASEPLATE AT TIME OF IMPLANTATION. AFTER SEVERAL ATTEMPTS USING THE 1/2 HI FLEX INSERT IMPACTOR, IT WOULD NOT ENGAGE. MULTIPLE ATTEMPTS WERE MADE BY THE SURGEON TO GAIN ADEQUATE EXPOSURE, CLEAR THE BASEPLATE AND IRRIGATE TO ENSURE THERE WAS NOTHING STOPPING THE SUCCESSFUL ENGAGEMENT OF THE LOCKING MECHANISM. ANOTHER INSERT WAS THEN OPENED AND WAS SUCCESSFULLY IMPLANTED AND THE LOCKING MECHANISM ENGAGED ON FIRST IMPACTION. NO INJURY OR SURGICAL DELAY WAS REPORTED DUE TO THIS FAILURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10861716 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING TKA PROCEDURE, THE LEGION PS HIGH FLEX XLPE SIZE 1-2 11MM INSERT WAS TOTALLY LOCKED IN WHEN THE ANGLE BETWEEN TIBIA AND GROUND WAS 90 DEGREE; HOWEVER, THE INSERT WAS FALLING OFF WHEN THE DEGREE WAS FROM 90 TO 110 DEGREE. THE PROBLEM REPEATED AFTER TRYING SEVERAL TIMES, SO FINALLY A BACK-UP INSERT LEGION (GENESIS II) PS SIZE 1-2 11MM WAS USED TO COMPLETE THE SURGERY. A LESS-THAN-30-MIN DELAY WAS REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10037334 ↗
• InjuryDec 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury

  MAUDE report 9527958 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO THE INFECTION AND LOOSENING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 AND GII FEM COMPONENT(71420052), GII TIB BASE (71420180), LEGION INSERT (71453202), PATELLA (71420580). ALL OF THE IMPLANTED DEVICES WERE REVISED. THE REVISED DEVICES WILL NOT BE RETURNED. THE DOCTOR DOES NOT CONSIDER AS THE FAILURE OF DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 9356864 ↗
• InjuryJul 23, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WILL BE PERFORMED DUE TO FALL OF THE PATIENT, CAUSING A DISASSOCIATION OF THE DEVICE.

  Patient problems: Fall

  MAUDE report 7711422 ↗
• InjuryMar 1, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A DELAY GREATER THAN 30 MINUTES OCCURRED DURING SURGERY DUE TO THE INSERT NOT LOCKING ON THE TIBIAL BASEPLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7305783 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY OF KNEE. A PART OF INSERT WHICH REMOVED LACKED SO THE SURGEON WANTS TO KNOW THE REASON WHY IT WAS LACKED.

  Patient problems: Injury

  MAUDE report 6993148 ↗

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-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
• 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