EMPERION 71291102Recalls & reported problems
Smith & Nephew, Inc. · EMPERION 11 STEM PRIMARY HO · 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010561381), received between Jun 21, 2017 and Nov 5, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Break1
Patient problems
- Injury2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2022Fracture; Fracture
IT WAS REPORTED THAT AFTER A THR REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 , IT WAS IDENTIFIED THAT THE EMP 11 STEM PRIMARY HO WAS FRACTURED AT THE STEM/NECK JUNCTION ON (B)(6) 2022 . THIS EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 15740872 ↗InjuryMay 19, 2018Break; Break
IT WAS REPORTED THAT THE LEFT FEMORAL STEM BROKE INSIDE THE PATIENT, SO A SURGICAL INTERVENTION WAS PERFORMED AND THE STEM WAS REMOVED. ALSO PATIENT PRESENTED METALLOSIS.
Patient problems: Injury
MAUDE report 7528488 ↗InjuryJun 21, 2017Fracture; Fracture
IT WAS REPORTED IN A PUBLICATION THAT THREE PATIENTS HAD REVISIONS DUE TO FRACTURE OF THE STEM. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Injury
MAUDE report 6656105 ↗
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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