LEGION 71423235Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556030400), received between Nov 26, 2018 and Jan 12, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 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.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE LEGION PS NP FEM SZ 5 RT SLIPPED OFF, CAUSING AN AVULSION FRACTURE OF THE FEMUR. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A DELAY WAS PRESENTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24048657 ↗
• InjuryJan 6, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, EVER SINCE A RIGHT TKA SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAS EXPERIENCED A SEVERE PAIN IN THE RIGHT KNEE AND THE RHEUMATOLOGIST SAID IT COULD BE REACTION TO THE IMPLANT. IT IS CURRENTLY UNKNOWN HOW THIS ISSUE IS BEING TREATED.

  Patient problems: Arthralgia

  MAUDE report 21080687 ↗
• InjuryAug 9, 2023Adverse 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) 2022, THE PATIENT HAD AN INFECTED KNEE. A WASHOUT AND REVISION SURGERY WERE PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. IN ADDITION, A LEGION PS NP FEM SZ 5 RT AND A GII P/S ALL POLY TIB SZ3 15MM RT WERE REPLACED WITH S+N DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 17487143 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2022, A PATIENT UNDERWENT SURGICAL TREATMENT FOR OSTEOARTHRITIS OF THE RIGHT KNEE JOINT, THE SURGERY WAS SUCCESSFULLY COMPLETED, AND A LEVEL PS NP FEM SZ 5 RT WAS IMPLANTED. HOWEVER, ON (B)(6) 2023, TWO MONTHS AFTER SURGERY, THE SURGICAL INCISION RUPTURED, CAUSING A DELAYED HEALING. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16943132 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN OF UNKNOWN ORIGIN AS PRIMARY DIAGNOSIS. APPROXIMATELY TWENTY ONE (21) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED JOINT INSTABILITY OF THE REVISED KNEE PROSTHESIS AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16219207 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Arthralgia; Fibrosis; Medical device site infection; Osteolysis

  MAUDE report 11106262 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2017. IT IS UNKNOWN THE REASON OF THE MUA. PRIOR TO THE MUA THE PATIENT HAD LOST 5 TO 10 DEGREES OF FLEXION.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 11106254 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8374586 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8101718 ↗

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-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.
• 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.