LEGION 71453213Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00885556034941), received between Jul 23, 2018 and Jul 8, 2025 — classified as 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; 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 A KNEE INFLAMMATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH SURGEON DECIDED TO WASHOUT OUT THE KNEE AND EXCHANGE THE ARTICULAR INSERT. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 22443898 ↗
• InjuryMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN 2018, THE PATIENT EXPERIENCED SOME INSTABILITY IN THEIR KNEE, ENOUGH TO WARRANT SURGERY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH THE LGN PS HIGH FLEX XLPE SZ 3-4 13MM WAS EXPLANTED, SINCE UPON OPENING UP THE KNEE A SMALL PIECE OF PLASTIC FROM THE POST WAS FOUND IN THE BOX. THERE WAS A SMALL SLIVER OF PLASTIC FROM THE POST THAT WAS FREE FROM THE INSERT. CURRENT HEALTH STATUS OF PATIENT IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 21734561 ↗
• InjuryDec 6, 2024Adverse 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 UNSPECIFIED DATE, THE PATIENT FELL DOWN AND STARTED HAVING PAIN. THEREFORE, ON (B)(6) 2024, THEIR LGN PS HIGH FLEX XLPE SZ 3-4 13MM WAS SWAPPED FOR A 3-4 13 HIGH FLEX INSERT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Arthralgia; Fall

  MAUDE report 20873243 ↗
• InjuryAug 3, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE AT AN UNKNOWN TIME, THE PATIENT PRESENTED INSTABILITY. ACCORDING TO THE SURGEON DUE TO WEAR OVER TIME OF THE LGN PS HIGH FLEX XLPE SZ 3-4 13MM. A REVISION SURGERY TOOK PLACE ON (B)(6) 2023 TO EXCHANGE IT. PATIENT CURRENT HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 17450559 ↗
• InjuryMay 4, 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT LET TO A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14283307 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT EXPERIENCED INFECTION AND SWOLLEN. THIS ADVERSE EVENT WAS SOLVED BY A SYNOVECTOMY TO REMOVED THE LGN PS HIGH FLEX XLPE SZ 3-4 13MM AND WASHED THE JOINT OUT USING BETADINE AND PEROXIDE ON (B)(6) 2021. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13111096 ↗
• InjuryNov 7, 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) 2014, THE PATIENT EXPERIENCED AN INFECTION THAT WAS ADDRESSED VIA INFECTION INCISION AND DRAINAGE WITH LGN PS HIGH FLEX XLPE SZ 3-4 13MM REPLACEMENT ON (B)(6) 2021. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12756283 ↗
• InjurySep 22, 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) 2019 THE PATIENT SUFFERED FROM PAIN AND INSTABILITY. A REVISION SURGERY WAS NECESSARY TO ADDRESS THIS ADVERSE EVENT. THE PATIENT RECEIVED A TKA SYSTEM WITH UNKNOWN DEVICES. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12516922 ↗
• MalfunctionMar 1, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, A LEGION PS HIGH FLEX XLPE ARTICULAR INSERT SZ 3-4 13MM WOULD NOT LOCK INTO PLACE/SEAT ON THE LATERAL SIDE OF THE KNEE. INCIDENT OCCURRED DURING A PRIMARY TKA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30 MIN USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11391147 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A KNEE DISLOCATION. OVER THE YEARS THE KNEE LOOSENED. THE PATIENT SUFFERS SOFT TISSUE LOOSENING. THE POLY WAS REPLACED WITH A CONSTRAINED INSERT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Joint Dislocation; Joint Laxity; Subluxation

  MAUDE report 11276585 ↗
• MalfunctionAug 19, 2020Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT THE POLY DID NOT SEAT PROPERLY ON THE LATERAL SIDE. THE SURGEONS MENTIONED THAT THE REPLACEMENT POLY NEITHER SEATED CORRECTLY. IT´S UNKNOWN WHEN THE EVENT OCCURRED AND HOW WAS THE PROCEDURE FINISHED. 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 10427054 ↗
• MalfunctionAug 19, 2020Defective Device; Connection Problem; Defective Device; Connection Problem

  IT WAS REPORTED THAT THE POLY DID NOT SEAT PROPERLY ON THE LATERAL SIDE. THE SURGEONS MENTIONED THAT THE REPLACEMENT POLY NEITHER SEATED CORRECTLY. IT´S UNKNOWN WHEN THE EVENT OCCURRED AND HOW WAS THE PROCEDURE FINISHED. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10427018 ↗
• InjuryAug 18, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A REVISION OF LEFT TKR WAS PERFORMED DUE TO PATIENT PRESENTING WITH PAIN WITH SLIGHT MALALIGNMENT/MALROTATION OF IMPLANT COMPONENTS. PRIMARY LEFT TKR WAS PERFORMED ON (B)(6) 2017. DURING REVISION SURGERY THE LEGION POSTERIOR STABILIZED HIGH FLEX HIGHLY CROSS LINKED POLYETHYLENE WAS REMOVED WITH RENOVATION KNEE GEAR. ORIGINAL OVAL 32MM PATELLA WAS RETAINED BY SURGEON. BONY CANALS AND SURFACES WERE PREPPED FOR A 5 LEFT LEGION REVISION FEMUR, 3 LEFT REVISION TIBIA WITH TIBIAL AND FEMORAL STEMS USED WITH OFFSET COUPLERS AND AUGMENTED FEMORAL COMPONENT. THE COMPONENTS WERE TRIALLED WITH ROM CHECK BEFORE IMPLANTATION. THE COMPONENT IMPLANTS USED WERE CEMENTED IN WITH PALACOS CEMENT AND CONSTRAINED 3-4 18MM INSERT IMPLANTED AFTER CEMENT CURING. THE WOUND WAS WASHED AND IRRIGATED, AND BETADINE/SALINE SOAKED, AND THEN CLOSED IN LAYERS AS PER STANDARD TECHNIQUE.

  Patient problems: Injury

  MAUDE report 10418683 ↗
• MalfunctionJul 16, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A LEGION REVISION TKA SURGERY IT WAS IMPLANTED A LEGION TIBIAL BASE PLATE. WHEN SURGEON WAS ATTEMPTING TO INSERT THE 3-4 13MM CONSTRAINED POLY IT WOULD NOT LOCK DOWN. A SECOND HIGH FLEX LEGION POLY WAS OPENED AND ATTEMPTED TO BE INSERTED IN AND WOULD NOT LOCK IN AS WELL. EACH POLY WAS INSERTED MULTIPLE TIMES AND POPPED OUT WITH A INSTRUMENT WITH MINIMUM ANTERIOR PRESSURE. IT WAS THEN DECIDED AFTER SEVERAL ATTEMPTS TO LEAVE THE CONSTRAINED INSERT IN DUE TO THE TIBIAL BASEPLATE BEING CEMENTED. KNEE SEEMED STABLE WITHOUT THE POLY MOVING. A DELAY GREATER THAN 30 MIN WAS REPORTED. 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 10286058 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED DUE TO A BROKEN POST DUE TO A FALL. THE EXACT SAME COMPONENT WAS REPLACED DUE TO HER HISTORY. THERE WAS NO NEED FOR FURTHER CONSTRAINT. ALL OTHER COMPONENTS APPEARED TO BE IN GOOD CONDITION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10160121 ↗
• InjuryJan 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE POLY WAS REMOVED, THE KNEE WAS WASHED OUT AND A NEW POLY WAS INSERTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9610248 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LEFT REVISION SURGERY WAS PERFORMED DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8920344 ↗
• InjuryMay 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A WASHOUT AND REVISION OF POLYETHYLENE INSERT WAS PERFORMED DUE TO A LARGE HAEMATOMA AND SOFT TISSUE LAXITY. PATIENT EXPERIENCED A BLOOD CLOT POST OPERATIVE AND THEN AFTER BEING ANTICOAGULATED, HAS DEVELOPED A VERY LARGE HAEMATOMA INSIDE THE KNEE. THIS WAS EXCISED AND WASHED OUT, AND NEW INSERT WAS INSERTED.

  Patient problems: Injury

  MAUDE report 8574233 ↗
• InjurySep 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED DUE TO A SEPTIC ARTHRITIS DEVELOPMENT. AN INCISION AND DRAINAGE WITH IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON THE LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7921269 ↗
• InjuryJul 23, 2018Unstable; Unstable

  POLY EXCHANGE FOR UNSTABLE TOTAL KNEE.

  Patient problems: Joint Disorder

  MAUDE report 7712725 ↗

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-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
• 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