LEGION 71421265Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556234006), received between Nov 7, 2019 and Dec 20, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Aug 31, 2023Class IIOpen, Classified

   The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

   Z-2621-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

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.

• MalfunctionDec 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET-UP FOR A TKA SURGERY, THE INNER SEAL OF THE LEGION NARROW PS OXIN SZ 5N LT WAS FOUND TO BE LIFTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370346 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT COMPLAINED OF KNEE DISCOMFORT FOLLOWING A PRIMARY TKA ON (B)(6) 2020. SURGEON DIAGNOSED THE JOINTLINE WAS TOO HIGH. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REPLACE ONE (1) GNS II CON INS SZ 3-4 15MM AND ONE (1) LEGION NARROW PS OXIN SZ 5N LT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 16415114 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY. CURRENT HEALTH STATUS OF PATIENT IT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12388270 ↗
• MalfunctionDec 31, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION JUST BEFORE A TKA IT WAS NOTICED THAT THE LEGION NARROW PS OXIN SZ 5N LT HAD A RED WAX-LIKE SUBSTANCE ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH MINIMAL DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11100144 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE NURSE OPENED THE FEMORAL COMPONENT AND THERE WAS A RED WAX LOOKING MATERIAL ON THE INSIDE OF THE IMPLANT. WE OPENED A NEW IMPLANT AND IT WAS NORMAL. NO FURTHER INFORMATION WAS PROVIDED IT IS UNKNOWN IF THERE WAS A CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096763 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE LEFT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED

  Patient problems: Pain

  MAUDE report 9293546 ↗

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-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5