ECHELON 71344415Recalls & reported problems
Smith & Nephew, Inc. · ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR WITH HYDROXYAPATITE SIZE 15 LEFT · Class 2 · Implant
All models of ECHELON (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556023525), received between Nov 15, 2017 and Sep 16, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
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
Device problems
- Fracture1
- Migration or Expulsion of Device1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2020Fracture; Fracture
IT WAS REPORTED THAT A LEFT TOTAL HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE. PREVIOUS TO THIS REVISION ANOTHER REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 WHICH WAS ALSO PERFORMED FOR PERIPROSTHETIC FRACTURE (DISTAL TO FEMORAL PROSTHESIS (NOT A SMITH AND NEPHEW PRODUCT)) FOR THIS SURGERY AN ECHELON STEM WAS IMPLANTED WITH OXINIUM HEAD BUT PATIENT REFRACTURED PROXIMAL FEMUR. REVISION SURGERY WAS PERFORMED, REMOVING STEM AND FEMORAL HEAD. A NEW LARGER FEMORAL STEM IMPLANTED, AND FEMUR CABLED WITH STRUT BONE GRAFT FOR ADDITIONAL SUPPORT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Bone Fracture(s)
MAUDE report 10543558 ↗InjuryNov 15, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT PATIENT COMPLAINED ON PAIN IN HIP, X-RAYS WERE TAKEN AND STEM SUBSIDENCE WAS NOTED. TIME WAS GIVEN FOR SHAFT FRACTURE TO UNITE BEFORE FURTHER REVISION SURGERY WAS UNDERTAKEN. FEMORAL STEM AND FEMORAL HEAD WERE REVISED.
Patient problems: Failure of Implant
MAUDE report 7032024 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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