LEGION 71421264Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556233955), received between Apr 24, 2019 and Sep 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

• MalfunctionSep 19, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE LEGION NARROW PS OXIN SZ 4N LT WAS LABELED ON BOX AS A LEGION NARROW PS OXIN SZ 5N LT, BUT JUST BEFORE IMPLANTING IT, THE SURGEON NOTICED THAT THE STICKERS INDICATED IT WAS A 4N LEFT NARROW FEMUR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774704 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2017 USING OXINIM TECHNOLOGY BY SMITH & NEPHEW, THE PATIENT HAS HAD PAIN AND HAS BEEN LIMPING FOR OVER A YEAR. IT WAS NOTICED ON A BONE SCAN THAT THE JOINT IS LOOSE AS THE CEMENT DID NOT STICK AND A REVISION SURGERY NEED TO BE PERFORMED, BUT IT HAS NOT BEEN SCHEDULED AS OF TODAY.

  Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Failure of Implant; Implant Pain; Inadequate Pain Relief; Joint Laxity; Pain; Subluxation

  MAUDE report 10976883 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, WHILE REMOVING FEMORAL COMPONENT DUE TO TIBIA LOOSENING, SIGNIFICANT LOSS OF BONE OCCURRED.

  Patient problems: Injury

  MAUDE report 8547009 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112941, K230653. 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