LEGION 71423244Recalls & reported problems
Smith & Nephew, Inc. · LEGION POROUS CRUCIATE RETAINING FEMORAL SIZE 4 LEFT · Class 2 · Implant
All models of LEGION (446)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556030936), received between Nov 2, 2022 and Mar 26, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K073325, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inaccurate Information1
- Insufficient Device Problem Information1
Patient problems
- Loss of Range of Motion2
- Fibrosis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2019, THE CLINICAL SUBJECT EXPERIENCED LEFT KNEE ARTHROFIBROSIS. THIS ADVERSE EVENT WAS TREATED WITH PHYSICAL/PHYSIO THERAPY AND MANIPULATION UNDER ANESTHESIA. THE CURRENT OUTCOME OF THE PATIENT IS RECOVERED/RESOLVED.
Patient problems: Fibrosis; Loss of Range of Motion
MAUDE report 24699054 ↗InjuryNov 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED (B)(6) 2023, THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. THE ISSUE WAS SOLVED WITH MANIPULATION UNDER ANESTHESIA WITH INTRAARTICULAR STEROID AND LOCAL ANESTHETIC INJECTION. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE.
Patient problems: Loss of Range of Motion
MAUDE report 18209916 ↗MalfunctionNov 2, 2022Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE CHART-STICKS LABELS ENCLOSED WITHIN THE PACKAGE OF A LGN POROUS CR FEM SZ 4L (PN 71423244, LN 20DHA0034) WERE FOUND WRONG AS THEY CARRY THE ITEM DATA ANTHEM FEMORAL PS COCR SIZE 4 RIGHT (PN 71422834, LN 21JM11186). THERE WAS NOT ANY ISSUE WITH THE DEVICE; IT WAS ONLY THE LABELING ON THE INSIDE PACKAGING WRONG. THERE WAS NOT ANY IMPACT TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15716759 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K073325, K230653. One submission often covers many models, so check the product and lot details in each record.
- Z-2621-2023 · Aug 31, 2023 · Open, Classifiedsmith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-610-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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