LEGION 71453122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556035139), received between Apr 25, 2017 and Mar 6, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K071071); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY 20 YEARS AFTER A LEFT TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2023 TO EXCHANGE THE LGN CR HIGH FLEX XLPE SZ 5-6 11MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16491377 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH A LGN CR HIGH FLEX XLPE SZ 5-6 11MM WAS EXPLANTED AND EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 13087668 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE LGN CR HIGH FLEX XLPE SZ 5-6 11MM WAS EXCHANGED DUE TO A KNEE INFECTION ON (B)(6) 2021. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12573138 ↗
• InjuryDec 18, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, DURING A TKR WASHING, AT THE TIME OF OPENING THE PATIENT, THERE WAS A LARGE AMOUNTS OF PUS PRESENT, SO THE TKR IMPLANTS WERE REMOVED DUE TO INFECTION AND CEMENT SPACER WAS INSERTED. 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: Osteolysis; Unspecified Infection

  MAUDE report 11042018 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT APPARENTLY SHOWS SOME ALLERGIC REACTION TO THE SYSTEM IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9211445 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED DUE TO PAIN AND SWELLING. NO INFECTION. ALL IMPLANTS WERE REMOVED EXCEPT THE PATELLA. SURGEON DOES NOT BLAME THE IMPLANT.

  Patient problems: Pain

  MAUDE report 9187447 ↗
• InjuryFeb 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INCREASING PAIN. NO DELAY TO PROCEDURE WAS REPORTED.

  Patient problems: Injury; Pain

  MAUDE report 8348222 ↗
• InjuryApr 25, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT WAS ADMITTED FOR MECHANICAL FAILURE OF INTERNAL JOINT PROSTHESIS, LEFT KNEE. PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2017 FOR REVISION OF LEFT TOTAL KNEE ARTHROPLASTY, SYNOVECTOMY AND DEBRIDEMENT. PER OPERATIVE NOTE, THE PREVIOUS 11 MM THICK POLYETHYLENE INSERT DEMONSTRATED LATERAL SIDED WEAR AND EXAMINATION UNDER ANESTHESIA INTRA-OPERATIVELY DEMONSTRATED INSTABILITY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6518440 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071071. One submission often covers many models, so check the product and lot details in each record.

• 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-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