LEGION 71453252Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556255858), received between Apr 4, 2020 and Mar 19, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Fracture; Material Deformation

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE 10 YEARS AGO, THE PATIENT EXPERIENCED THE BREAKAGE OF THE POST OF ONE (1) LGN XLPE PS INSERT SZ 5-6 11MM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE IMPLANT WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24638232 ↗
• InjuryJun 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN 2010. THE PATIENT EXPERIENCED A BROKEN POST OF THE LGN XLPE PS INSERT SZ 7-8 13MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Failure of Implant

  MAUDE report 19499561 ↗
• InjuryDec 12, 2023Manufacturing, Packaging or Shipping Problem; Positioning Problem; Manufacturing, Packaging or Shipping Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A TKA A LGN XLPE PS INSERT SZ 5-6 9MM HAD A MANUFACTURING PROBLEM. SURGEON ATTEMPTED TO IMPLANT THE POLY INTO THE TIBIA BASEPLATE WITH A TOTAL OF 3 POLYS. I DID PRODUCT COMPLAINTS ON THE FIRST 2, WHILE THE 3RD WAS SUCCESSFULLY IMPLANT. DURING THE ATTEMPTS TO IMPLANT THE FIRST 2, NEITHER POLY SEEMS TO WANT TO ENGAGE THE TIBIA LATERALLY. THE SURGEON ATTEMPTED PROBABLY 5-10 TIMES TO IMPLANT BOTH OF THE FIRST 2 POLYS OPENED. AFTER MAKING MORE SOFT TISSUES RELEASES THAN HE NORMALLY WOULD, HE PURPOSEFULLY TRIED TO ENGAGE LATERALLY AND EVENTUALLY GOT IT TO ENGAGE. THE SURGEON SAID HE THOUGHT THERE SEEMED TO BE AN ISSUE WITH THE TIBIA BASEPLATE LATERALLY BECAUSE IT DIDN¿T WANT TO ENGAGE THE POLY AS IT TYPICALLY WOULD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18312982 ↗
• InjuryApr 26, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2012, THE LGN XLPE PS INSERT SZ 5-6 9MM BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE INTO A NEW POLY. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

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

  MAUDE report 14212602 ↗
• InjuryMar 10, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE BOX OF THE LGN XLPE PS INSERT SZ 5-6 9MM WAS BEING OPENED, DR REALIZED THERE APPEARED TO BE AN OPENING IN THE PACKAGE. DR WANTED TO SWITCH TO A DIFFERENT POLY TO AVOID POTENTIAL CONTAMINATION. DUE TO INVENTORY CONSTRAINTS A DIFFERENT INSERT WAS USED. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449987 ↗
• MalfunctionNov 18, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE LEGION XLPE PS INSERT SIZE 5-6 9MM WOULD NOT ENGAGE IN TIBIAL BASE PLATE. EVENT OCCURRED DURING USE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. A DELAY OF 30 MIN OR LESS WAS REPORTED. NO INJURY TO THE PATIENT 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 10861592 ↗
• MalfunctionNov 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE LOCKING MECHANISM ON THE LGN XLPE PS INSERT SZ 5-6 9MM DID NOT ENGAGE IN THE BASE PLATE. A DELAY OF LESS THAN 30 MIN WAS REPORTED. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. 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 10855141 ↗
• InjuryAug 20, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF GENESIS II 7.5MM RESURFACING PATELLA 35MM ((B)(4)). THE PATELLA WAS DISASSOCIATED FROM BONE RESULTING IN NEED FOR REVISION SURGERY. NO ACUTE FALL, INJURY OR ADVERSE EVENT PRIOR TO REVISION SURGERY WAS REPORTED. STRYKER SIMPLEX HV WITH GENT WERE USED FOR PATELLA. THE SURGEON ALSO CONCERNED WITH THE AMOUNT OF "PITTING" ON THE LEGION XLPE PS INSERT SZ 5-6 9MM ((B)(4)) AFTER ONLY 4 YEARS OF PRIMARY IMPLANTATION, AND DECIDED TO REPLACE IT AS WELL.

  Patient problems: Injury

  MAUDE report 10433840 ↗
• InjuryApr 4, 2020Adverse 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.

  Patient problems: Unspecified Infection

  MAUDE report 9926194 ↗

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-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-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