Skip to content

EMPERION 71291501Recalls & reported problems

Smith & Nephew, Inc. · EMPERION 15 STEM PRIMARY SO · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010561527), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2015 PATIENT PRESENTED PAIN AND LEG-LENGTH DISCREPANCY, MRI DEMONSTRATE MECHANICAL FAILURE OF THE FEMORAL COMPONENT. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 WHERE IT WAS CONFIRMED CORROSION A FEMORAL COMPONENT BREAKAGE. ALL IMPLANTS WERE REMOVED. PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Pain

    MAUDE report 8395263 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.