LEGION 71423237Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556031292), received between Sep 28, 2018 and Jan 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2023, PATIENT EXPERIENCED PAIN AND REQUIRED A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF ALL COMPONENTS. DURING THE REVISION THAT TOOK PLACE ON (B)(6) 2024, MINIMAL CEMENT MANTLE WAS NOTICED AND THE IMPLANTS WERE REMOVED QUITE EASILY FROM THE BONE. ADDITIONALLY, BOTH-THE LEGION PS NP FEM SZ 7 RT AND GNS II NON-POR TIB SZ 7 RIGHT APPEARED TO BE SLIGHTLY OVERSIZED. PATIENT RETURNED TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthralgia; Aseptic loosening; Pain

  MAUDE report 21080649 ↗
• InjuryNov 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY RIGHT TKA SURGERY IN 2021 DUE TO DEGENERATIVE ARTHRITIS. DURING THIS SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 1.19 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20791569 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2021 DUE TO ARTHRITIS IN PREVIOUSLY UN-RESURFACED COMPARTMENT. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.5 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED A TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19459570 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2023, DUE TO OSTEOARTHRITIS, THE PATIENT DID INTENSE EXERCISE AFTER DISCHARGE, EXPERIENCED JOINT PAIN IN THE RIGHT KNEE ON (B)(6) 2023 AND FOUND THE WOUND HAVE CRACKED ABOUT 1CM. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT ON (B)(6) 2023. THE RESULTS OF THE HEMATOLOGICAL EXAMINATION SHOWED AN INCREASE IN WHITE BLOOD CELL COUNT AND C-REACTIVE PROTEIN INDEX, INDICATING AN INFECTION STATUS IN THE BODY. JOINT PUNCTURE FLUID INDICATED STAPHYLOCOCCUS AUREUS INFECTION. THIS ADVERSE EVENT WAS TREATED BY PROSTHESIS REMOVAL AND RIGHT KNEE JOINT RELEASE ON (B)(6) 2023. INTRAVENOUS INFUSION OF VANCOMYCIN WAS APPLIED AFTER THE SURGERY. THE PATIENT WAS DISCHARGED AFTER THE INFLAMMATION VANISHED.

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 18703151 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8844592 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT FELL AND INJURED HIS RIGHT KNEE. HE DIDN'T SEEK MEDICAL ASSISTANCE FOR 12 MONTHS. WITHIN THAT TIME THE TIBIAL BASE PLATE HAS PROGRESSIVELY GONE INTO VARUS CAUSING PAIN. DOCTOR BELIEVES THAT THE PATIENT FRACTURED UNDER THE TIBIAL TRAY IN THEIR FALL WHICH CAUSED THE TIBIAL TRAY TO FALL INTO VARUS.

  Patient problems: Pain

  MAUDE report 7919841 ↗

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-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-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.