ECHELON 71344412Recalls & reported problems
Smith & Nephew, Inc. · ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR WITH HYDROXYAPATITE SIZE 12 LEFT · Class 2 · Implant
All models of ECHELON (30)
Data updated Oct 16, 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 00885556023549), received between Feb 13, 2020 and Nov 19, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
Patient problems
- Bacterial Infection1
- Failure of Implant1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A JOINT CAPSULE INFECTION AND THE ECHELON HA STD 260 BOW S 12 L WAS BROKEN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE REF NO HOLE SHELL SZ 52MM, ECHELON HA STD 260 BOW S 12 L, OXINIUM FEM HD 12/14 32MM +8 AND AN UNKNOWN REFLECTION LINER WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Bacterial Infection; Failure of Implant
MAUDE report 12847152 ↗InjuryFeb 13, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AFTER A FALL ONTO THE LEFT HIP, SUBSEQUENT TO A FIRST REVISION HIP SURGERY. IMPLANTED DEVICES: SIZE 15 LEFT 260 STANDARD ECHELON STEM WITH ASSOCIATED CERAMIC HEAD 32 +4.
Patient problems: Injury
MAUDE report 9706231 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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