LEGION 71425216Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556108499), received between Apr 20, 2017 and Nov 7, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091543, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A BILATERAL TKA HAD BEEN PERFORMED ON (B)(6) 2022, ON (B)(6) 2022 THE PATIENT EXPERIENCED FIBROSIS ON THE RIGHT KNEE DUE TO INTERNAL ORTHOPEDIC PROSTHETIC DEVICES, IMPLANTS AND GRAFTS. WHICH INCLUDED, ONE (1) LGN POR CR HA FEM SZ 6 RT, ONE (1) POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 RT AND ONE (1) LGN CRHF XLPE INS W/JRNY LCK SZ 5-6 10MM. PATIENT REQUIRED MEDICATION AND MUA AS TREATMENT; THE PATIENT IS NOW RECOVERED.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 18084521 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY IN THE RIGHT KNEE ON (B)(6) 2017 PATIENT EXPERIENCED CELLULITIS IN THE RIGHT LOWER EXTREMITY. THIS ADVERSE EVENT WAS RESOLVED WITH MEDICATION; HOWEVER, IT REMAINS UNCLEAR WHAT CAUSED THE CELLULITIS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cellulitis

  MAUDE report 15709013 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED, THE IMPLANTS WERE REMOVED DUE TO SUSPECTED INFECTION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE LGN POR CR HA FEM SZ 6 RT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14247163 ↗
• InjuryApr 20, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A REVISION RIGHT KNEE SURGERY WAS PERFORMED DUE TO A LOOSE FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 6507951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091543, 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