LEGION 71453284Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556255643), received between Nov 3, 2017 and Jul 11, 2024 — classified as 8 injuries, 1 malfunction.

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

• InjuryJul 11, 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 ON (B)(6) 2023, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT, IN WHICH A LGN XLPE DISHED ISRT SZ 5-6 9MM WAS EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19721244 ↗
• InjuryNov 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED SOFT TISSUE INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE THE LGN XLPE DISHED ISRT SZ 5-6 9MM. THE POLYETHYLENE WAS UPSIZED. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12878050 ↗
• MalfunctionMay 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TKA, THE LEGION XLPE DISHED INSERT SIZE 5-6 9MM WOULD NOT LOCK INTO TIBIA CORRECTLY. NO PATIENT INJURY REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794871 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CHRONIC INFECTION IT WAS DECIDED TO EXPLANTED THE IMPLANTS, GII OXINIUM FEM SIZE 4 LEFT, GNS II CMT TIB SIZE 5 LEFT AND LGN XLPE DISHED ISRT SZ 5-6 9MM. SITE WAS WASHED OUT. ONCE WOUND WAS OPENED SAMPLES WERE TAKEN AND SENT TO HISTOLOGY. A COCR GENII FEMUR AND ALL POLY TIBIA WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11449955 ↗
• InjuryDec 29, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE DURING PROCEDURE IT WAS UNABLE TO GET THE LGN XLPE DISHED ISRT SZ 5-6 9MM TO SEAT CORRECTLY, AFTER MULTIPLE EFFORTS IT WAS DECIDED TO USE A 9MM CR HIGH FLEX INSERT . THE EXTRA TIME ADDED TO THE PROCEDURE WAS ABOUT 5-8MINS. NO INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11090049 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT GOT INFECTED AFTER HAVING A TOOTH EXTRACTED. DR. PERFORMED A WASHOUT AND A POLY EXCHANGE. AFTER REMOVING THE ORIGINAL POLY INSERT AND DEBRIDING SOFT TISSUE AND WASHING OUT THE KNEE, DR. REPLACED THE ORIGINAL POLY WITH THE SAME SIZE AND THICKNESS OF THE SAME DEEP DISHED POLY INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 9510650 ↗
• InjuryOct 3, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF THE DEVICE. SWEELING WAS REPORTED.

  Patient problems: Swelling

  MAUDE report 7930857 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH PAIN AND UNDERWENT ASPIRATION OF THE KNEE AND NERVE BLOCK ABLATION IN THE KNEE.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 7109901 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE THE DISHED INSERT DUE TO PAIN. DOCTOR DOESN'T BLAME THE IMPLANT TO BE THE CAUSE OF THE PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6999906 ↗

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-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-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-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