EMPERION 71291669Recalls & reported problems
Smith & Nephew, Inc. · EMPERION 13 SLEEVE LARGE CONE 3 SPOUT · Class 2 · Implant
All models of EMPERION (14)
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 03596010561749), received between Feb 20, 2018 and Sep 14, 2018 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
- Fracture1
Patient problems
- Injury2
- Reaction, Injection Site1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED ON (B)(6) 2010 DUE TO SWELLING. RIGHT HIP BURSA WAS INJECTED.
Patient problems: Injury
MAUDE report 7879187 ↗InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ON (B)(6) 2011 A MEDICAL INTERVENTION WAS PERFORMED DUE TO PAIN. A STEROID INJECTION WAS PERFORMED TO TREAT SEVERE PAIN THE PATIENT WAS PRESENTING.
Patient problems: Reaction, Injection Site
MAUDE report 7878536 ↗InjuryFeb 20, 2018Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO A FRACTURE OF THE FEMORAL STEM. DURING THE SURGERY, METALLOSIS WAS SEEN IN THE TISSUES SURROUNDING THE HIP JOINT.
Patient problems: Injury
MAUDE report 7284264 ↗
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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