LEGION 71423236Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556031001), received between Dec 12, 2018 and Feb 27, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K060742, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SURGERY PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN, THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO REMOVE THE IMPLANTS. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13615112 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPARENTLY PATIENT KNEE NEVER SETTLED AND CAUSED HIM PAIN. SURGEON SUSPECTED A LOW-GRADE INFECTION BUT LAB TESTS COULD NOT CONFIRM IT. PATIENT HAD A SECOND REVISION SURGERY TO REMOVE THE IMPLANT AND INSERT A CEMENT SPACER. PRIMARY KNEE REPLACEMENT PERFORMED ON THE (B)(6) 2019. ON THE (B)(6) 2019 PATIENT HAD A FIRST REVISION SURGERY TO EXCHANGE THE POLY AND PERFORM A WASHOUT (THIS EVENT WAS REPORTED AT THE TIME).

  Patient problems: Injury; Pain

  MAUDE report 9938667 ↗
• InjurySep 30, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS REPORTED DUE TO INSTABILITY AND PAIN. THE FEMORAL COMPONENT, THE BASEPLATE AND THE INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 9137591 ↗
• InjuryDec 12, 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 RIGHT KNEE INSTABILITY STATUS POST TOTAL KNEE REPLACEMENT. TIBIAL COMPONENT, TIBIAL BASEPLATE AND POLY INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8156775 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8155627 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH RIGHT KNEE STIFFNESS STATUS POST REVISION, AND RIGHT KNEE REPLACEMENT. A MANIPULATION UNDER ANESTHESIA AND AN INJECTION OF PAIN COCKTAIL CONTAINING TORADOL, MORPHINE, EPINEPHRINE AND BUPIVACAINE, IN PERIARTICULAR TISSUES AND INTRA-ARTICULARLY WERE PERFORMED.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8155271 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS MORE THAN THREE MONTHS STATUS POST HER SURGERY, FAILED TO REGAIN FULL RANGE OF MOTION ON HER RIGHT KNEE. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED AND AN INJECTION FOR PAIN CONTROL POSTOPERATIVELY WAS APPLIED ON HER RIGHT KNEE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8155000 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060742, 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-0590-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0591-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0589-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.