ECHELON 71340112Recalls & reported problems
Smith & Nephew, Inc. · ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 12 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010328717), received between May 8, 2015 and May 22, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K211176, K983834); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Insufficient Device Problem Information1
Patient problems
- Injury2
- Pain2
- Failure of Implant1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAD A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND 5 YEARS LATER STARTED HAVING PAIN. A BONE SCAN CONFIRMED LOOSENING AND FAILURE OF INGROWTH PROXIMAL ON THE POROUS AREA AND, INTRAOPERATIVELY, IT WAS NOTED THAT STEM WAS FRACTURED AND IT WAS REMOVED THROUGH AN EXTENDED TROCHANTERIC OSTEOTOMY.
Patient problems: Pain
MAUDE report 8634417 ↗InjuryJul 7, 2017Fracture; Fracture
IT WAS REPORTED THAT A REVISION WAS DONE DUE TO PAIN. X-RAY SHOWED THAT THE STEM WAS FRACTURED.
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 6692673 ↗InjuryMay 8, 2015Fracture
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
Patient problems: Injury; Insufficient Information; No Code Available
MAUDE report 4759383 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K983834. One submission often covers many models, so check the product and lot details in each record.
- Z-0326-2025 · Oct 15, 2024 · Open, ClassifiedTandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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