LEGION 71421274Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556234150), received between May 24, 2024 and Mar 14, 2026 — classified as 3 injuries.

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

3 other recalls cover devices cleared under the same FDA submission (K112941); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN AND KNEE STIFFNESS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ALL PRIMARY TKR IMPLANTS WERE REMOVED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24600343 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA SURGERY WAS PERFORMED ON 27-MAR-2023, FROM EARLY POSTOPERATIVE ONSET, THE PATIENT REPORTS TO FEEL HER KNEE OUT OF WHACK/ALIGNMENT AT TIMES AND IT CATCHES OR CLICKS. IN A RECENT OCCASION, THE PATIENT HAD TO TRY TO MOVE HER PROTHESIS AND MASSAGED IT TO GET IT BACK. PATIENT REPORTED THAT SHE IS NOT ABLE TO KNEEL AS IT IS HARD TO GET UP; IS DIFFICULT TO GET DOWN TO THE FLOOR OR BATH.; AND EXPERIENCE INSTABILITY GETTING OUT OF POOLS OR HOT TUBS. PATIENT REPORTS TO FEEL DISCOMFORT DAILY (PARTICULARLY AT THE END OF THE DAY AND WHEN SHE STANDS FROM SITTING OR LYING), PAIN, STIFFNESS AND NUMBNESS AROUND KNEE AND DOWN HER ANTERIOR AND MEDIAL LOWER LEG (FRONT, SIDE). SHE MENTIONED SHE IS AWARE OF HER KNEE 95% OF EVERY DAY. PATIENT STARTED PHYSICAL THERAPY REGULARLY, WORKING ROM AND LEG STRAIGHTENING EXERCISES, ONE MONTH POSTOPERATIVE. SHE WAS NOT ADVISED TO KEEP HER LEG STRAIGHT IN THE WEEKS FOLLOWING SURGERY. DURING THE THREE MONTHS APPOINTMENT THE SURGEON ASKED HER IF SHE WAS MANIPULATING THE PATELLA. BY THIS TIME, SHE HAD IRREVERSIBLE SCAR TISSUE AND RANGE OF MOTION LOSS. THE KNEE AREA WAS WARM/HOT FOR APPROXIMATELY TEN MONTHS AND IS STILL WARMER THAN

  Patient problems: Discomfort; Joint Impingement; Joint Laxity; Loss of Range of Motion; Numbness; Pain; Scar Tissue

  MAUDE report 19463312 ↗
• InjuryMay 24, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TKA SURGERY PERFORMED ON (B)(6) 2024, IN WHICH A S+N OXINIUM FEMUR 4, A TIBIA 3 AND A LONG NON SLOTTED STEM OF SIZE 16X100 MM WERE IMPLANTED. THE SAME DAY WEIGHT BEARING, MOBILIZATION, STAIR CASE AND COMMODE TRAINING WERE ACHIEVED BEFORE DISCHARGE ON POD5. A FOLLOW-UP WAS SCHEDULED 10 DAYS POST-OPERATIVE, IN WHICH THE PATIENT'S WOUND WAS INSPECTED AND FOUND HEALTHY, THE PATIENT WAS ALSO PAIN FREE AND MENTIONED THAT SHE HAS BEEN DOING SOME EXERCISES. AFTER 6 WEEKS OF SURGERY, IN THE NEXT FOLLOW-UP THE PATIENT COMPLAINT OF PAIN AND SWELLING ON THE RIGHT KNEE. THE PATIENT WAS COMFORTABLE ONLY FOR 1 MONTH AFTER THE SURGERY. ON EXAMINATION IT WAS NOTICED THAT THERE WAS LOCAL RISE OF TEMPERATURE AND REDNESS OF THE RIGHT KNEE. AFTER 3 MONTHS POST-SURGERY THE SYMPTOMS GET BETTER ONLY WHEN TAKING SHORT COARSE TAPERING DOSES OF MEDROL, BUT AS SOON AS SHE STOPS THE MEDICATION, THE SYMPTOMS REAPPEAR. ALL INVESTIGATIONS-MR, INFECTION MARKERS, CT SCANS FOR MALROTATION ARE CLEAR. THE IGE IS RAISED AS MARKER FOR ALLERGIES. SURGEON IS POTENTIALLY CONSIDERING REVISION OF THE OXINIUM IMPLANTS.

  Patient problems: Erythema; Implant Pain; Inflammation; Swelling/ Edema

  MAUDE report 19393330 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112941. One submission often covers many models, so check the product and lot details in each record.

• Z-0282-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
• 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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5