LEGION 71453183Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556487341), received between Apr 18, 2021 and Jul 6, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2022Adverse 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, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO DOWNSIZED THE LGN CR HIGH FLEX XLPE SZ 3-4 10MM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14928247 ↗
• InjuryMay 24, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN (B)(6) 2016 WITH A LEGION POROUS SYSTEM, PATIENT FELT LEFT KNEE HEMATOGENOUS INFECTION. A LEFT KNEE INCISION AND DRAINAGE WITH REVISION OF ARTICULAR SURFACES TREATMENT WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 14490594 ↗
• InjuryMay 23, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016 WITH A LEGION POROUS SYSTEM, PATIENT FELT RIGHT KNEE HEMATOGENOUS INFECTION. A RIGHT KNEE INCISION AND DRAINAGE WITH REVISION OF ARTICULAR SURFACES TREATMENT WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 14480864 ↗
• InjuryMay 24, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SURGEON TRIED NUMEROUS TIMES TO GET THE ARTICULAR SURFACE TO SEAT ON THE LGN CR HIGH FLEX XLPE SZ 3-4 10MM, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THOUGHT THAT PERHAPS THE POLY LOCKING MECHANISM MIGHT BE COMPROMISED, SO HE THEN CHOSE TO INSERT A LGN CR HIGH FLEX XLPE SZ 3-4 11MM. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871667 ↗
• MalfunctionApr 18, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, THE INSERT OF A LGN CR HIGH FLEX XLPE SZ 3-4 10 MM WOULD NOT SEAT INTO THE TIBIA TRAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683543 ↗

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-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