LEGION 71453201Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556033784), received between Apr 12, 2017 and May 8, 2025 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY OF ONE (1) LGN PS HIGH FLEX XLPE SZ 1-2 9MM. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE POLYETHYLENE INSERT WAS EXCHANGED FOR A LARGER SIZE. THE PATIENT WAS DISCHARGED IN GOOD HEALTH.

  Patient problems: Joint Laxity

  MAUDE report 21990736 ↗
• InjuryOct 23, 2024Adverse 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) 2024, THE DOCTOR OBSERVED ELEVATED INFLAMMATION LEVELS IN THE PATIENT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY IN (B)(6) 2024, IN WHICH THE LINER WAS REPLACED WITH A DIFFERENT S+N PRODUCT. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation

  MAUDE report 20517135 ↗
• InjurySep 16, 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 IN (B)(6) 2017, THE PATIENT EXPERIENCED A MRSA INFECTION, PAIN AND FEELING OF WRONGNESS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2024, IN WHICH LGN PS HIGH FLEX XLPE SZ 1-2 9MM WAS EXCHANGED TO A LEGION INSERT. THE LEGION PS NP FEM SZ 4 LT, GNS II CMT TIB SIZE 2 {} LEFT AND GNS II RESURF PAT 32MM WERE REMAINED ON THE PATIENT. SURGEON BELIEVES THIS ADVERSE EVENT IS NOT RELATED TO A PRODUCT FAILURE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Drug Resistant Bacterial Infection; Pain

  MAUDE report 20225395 ↗
• InjuryMay 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED DISASSOCIATION OF THE LGN PS HIGH FLEX XLPE SZ 1-2 9MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS EXCHANGED. HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19323338 ↗
• InjuryApr 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON LITERATURE REVIEW "METALLOSIS AFTER OXINIUM TOTAL KNEE ARTHROPLASTY IN A PATIENT WITH RHEUMATOID ARTHRITIS: A CASE REPORT", ONE (1) PATIENT PRESENTED SWELLING AND A GROWING MASS IN THE INTERNAL ANGLE OF THE KNEE AFTER AN INDEX TKA PROCEDURE USING A GENESIS II SYSTEM. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY. THE POST OF THE POLYETHYLENE LINER WAS DETACHED, THE LINER DISLOCATED TOWARDS THE INTERNAL ANTERIOR KNEE COMPARTMENT AND DELAMINATION OF THE OXINIUM FEMORAL COMPONENT WAS NOTED. ADDITIONALLY, A PROFUSE METALLOSIS WAS OBSERVED. A SYNOVECTOMY WAS PERFORMED, AND THE INSERT WAS REPLACED WITH A NEW ONE OF THE SAME SIZE. THE PATIENT WAS DISCHARGED AFTER ONE WEEK.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 16747001 ↗
• InjurySep 8, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED DISASSOCIATION OF THE POLY. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, TO EXCHANGE THE LGN PS HIGH FLEX XLPE SZ 1-2 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15380848 ↗
• MalfunctionMar 15, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LGN PS HIGH FLEX XLPE SZ 1-2 9MM WAS NOT LOCKED EVEN AFTER MANY ATTEMPTS. INSTRUMENTS INSIDE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. 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 11479238 ↗
• MalfunctionMar 1, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING USE, INSIDE THE PATIENT, THE INSERT COULD NOT BE PLACED TO BASEPLATE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391224 ↗
• MalfunctionFeb 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY THE LEGION PS HIGH FLEX XLPE SIZE 1-2 9MM WASN¿T ABLE TO LOCK ON THE TIBIA TRAY FULLY. THERE WAS A 1MM SPACE NOTICED ON THE ANTERIOR LATERAL BETWEEN THE INSERT AND THE TIBIA TRAY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO 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 11256925 ↗
• InjuryJan 24, 2021Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POLY FRACTURE. POLY IS BROKEN MEDIALLY AND DISLODGED. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 11221032 ↗
• InjuryDec 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UPON X- RAY IMAGING LOOKS TO HAVE A BROKEN INSERT ON THE MEDIAL SIDE. THE PATIENT WILL BE SCHEDULED FOR A REVISION SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11091311 ↗
• InjuryJun 16, 2020Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE 1-2 9MM HIGH FLEXION POLY INSERT COULDN'T BE LOCKED. IT DIDN'T WORK AFTER KNOCKING AND TRYING FOR 20 MINUTES AND THERE ARE SCRATCHES. FINALLY, ANOTHER SAME SIZE CODE PRODUCT WAS USED TO COMPLETE THE SURGERY, WHICH INCREASES THE TOURNIQUET USE TIME OF 20 MINUTES IN SURGERY, WHICH INCREASES THE RISK OF THROMBUS IN PATIENTS, AND AFFECTS THE OPERATION PROCESS. 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 10159627 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DOING A LEGION KNEE REVISION AND WHEN THE SURGEON WAS PLACING THE INSERT, IT SNAPPED IN WITH NO IMPACTION. WHEN REDUCING THE JOINT THE INSERT POPPED OUT AS EASY AS IT POPPED IN. THE SURGEON TRIED A FEW MORE TIMES AND THE INSERT WOULD NOT STAY IN PLACE EVEN THOUGH IT WAS FULLY SEATED IN THE BASEPLATE. SURGERY WAS NOT DELAY AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 9587479 ↗
• InjuryNov 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO THE DISASSOCIATION OF INSERT. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016. THE REVISED DEVICE WILL BE RETURNED FOR EVALUATION. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9369632 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE RIGHT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED.

  Patient problems: Pain

  MAUDE report 9293540 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE LEFT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED

  Patient problems: Pain

  MAUDE report 9293532 ↗
• InjuryNov 5, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED TOTAL KNEE 4 YEARS AGO. A PROCEDURE WAS PERFORMED TO REMOVE WHAT WAS THOUGHT TO BE A LARGE BONE SPUR. IT WAS FOUND TO BE LARGE AMOUNTS OF TISSUE DAMAGED DUE TO METASTASIS. METASTASIS REPORTED BEING BECAUSE OF POLY DISLOCATION. THE SURGEON DECIDED TO LEAVE THE METAL COMPONENTS IN PLACE AND PERFORM A POLY SWAP BUT THE ORIGINAL SIZE APPEARED LOOSE DURING TRIALING LARGER SIZE IMPLANTED. ORIGINAL POLY WAS KEPT BY THE FACILITY.

  Patient problems: Injury

  MAUDE report 9280064 ↗
• InjuryOct 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9255858 ↗
• InjuryJan 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED PATELLAR CLUNK SYNDROME. INSERT REPLACEMENT AND SOFT TISSUE RESECTION WERE CONDUCTED.

  Patient problems: Injury

  MAUDE report 8209116 ↗
• MalfunctionJul 23, 2018Connection Problem; Connection Problem

  DURING TKA PROCEDURE, THE INSERT COULD NOT BE LOCKED INTO BASEPLATE (71420162/17LM00130). BACKUP (10MM) INSERT WAS IMPLANTED AS REPLACEMENT. NO PATIENT INJURY OR DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7712721 ↗
• InjuryJul 23, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION.

  Patient problems: No Code Available

  MAUDE report 7711080 ↗
• InjuryJun 22, 2018Adverse 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 INFECTION. DOCTOR DOESN'T FAULT THE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 7630800 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY AND WASH OUT WAS PERFORMED DUE TO INFECTION. PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 7404630 ↗
• InjurySep 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO SET THE NAIL DUE TO FRACTURE OF FEMORAL, THE NEW INSERT WAS NOT INSERTED INTO THE IMPLANTED OLD BASEPLATE. THEREFORE THE SURGEON SET THE OLD INSERT AGAIN.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6878650 ↗
• InjuryApr 12, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE PATIENT HAD PAIN.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 6485863 ↗

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-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-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-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