LEGION 71421275Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556234204), received between Oct 19, 2017 and Mar 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Recalls naming this device

1. Oct 2, 2024Open, Classified

   Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

   Z-0282-2025 · Root cause: Packaging change control · Recall details · FDA record ↗

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 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED IN AN UNSPECIFIED DATE, AN INFECTION DEVELOPED THAT LED TO MULTIPLE SURGERIES IN THE PATIENT AND MORE THEN 80 DAYS OF HOSPITALIZATION. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Medical device site infection

  MAUDE report 21725508 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Pain

  MAUDE report 9293544 ↗
• InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST TKA PATIENT DEVELOPED AN ORAL INFECTION, WAS DOING FINE UNTIL KNEE INFECTION DEVELOPED ALSO. FEMORAL, TIBIAL AND PATELLA COMPONENTS HAVE BEEN REMOVED, AND REPLACED WITH BIOMET CEMENT SPACERS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6960639 ↗

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-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