EMPERION 71290902Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010561275), received between Jun 21, 2017 and Aug 27, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (4 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER UNDERGOING A TOTAL HIP REPLACEMENT (THR) IN 2014 DUE TO UNKNOWN REASONS PATIENT SUFFERED BREAKAGE OF AN EMPERION STEM. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH THE EMP STEM 9 SO 140MM, HEAD AND LINER WERE EXCHANGED. DURING PROCEDURE, THEY ENCOUNTERED SIGNIFICANT SCLEROSIS ON THE DISTAL ASPECT OF THE SLEEVE, SO A DECISION WAS MADE TO START PREPARING A TROCHANTERIC OSTEOTOMY. HOWEVER, THERE HAD ALREADY BEEN A SMALL CRACK IN THE LATERAL ASPECT OF THE GREATER TROCHANTER. PATIENT WAS ON TOE TOUCH WEIGHTBEARING. SHE HAD STRICT ABDUCTOR PRECAUTIONS FOR SIX TO TWELVE WEEKS WHICH DEPENDED ON THE FOUR WEEK POSTOPERATIVE X-RAY. IN ADDITION, SEVEN WEEKS POST-OP PATIENT SHOWED ALIGNMENT AND APPEARANCE OF THE HARDWARE UNCHANGED AND WITHOUT ACUTE OSSEOUS COMPLICATION.

  Patient problems: Failure of Implant; Radiolucent Lines

  MAUDE report 20076040 ↗
• InjuryApr 26, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT THR ON (B)(6) 2015 DUE TO RIGHT HIP OSTEOARTHRITIS WITH LIMITED RANGE OF MOTION, THE PATIENT EXPERIENCED PAIN, GROIN TENDERNESS, LIMITED INTERNAL AND EXTERNAL ROTATION. CT SCAN SHOWED PROSTHETIC FRACTURE OF STEM AND X-RAYS CONFIRMED BROKEN STEM DISPLACED, FRACTURED, AND ANGULATED AT THE LEVEL OF THE GREATER TROCHANTER/INTERTROCHANTERIC REGION. THE PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP ON (B)(6) 2021. IT IS UNKNOWN THE STATUS OF THE PATIENT.

  Patient problems: Deformity/ Disfigurement; Failure of Implant; Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 14212753 ↗
• InjuryDec 31, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE/IMPLANT FAILURE. DUE TO WHERE THE FRACTURE OF THE PROSTHESIS WAS, COULDN'T USE EMPERION REMOVAL INSTRUMENTS AND REMOVAL OF STEM WAS DIFFICULT AS THE DISTAL STEM WAS WELL FIXED. THEN CUT BASE OF SLEEVE HOWEVER WAS UNABLE TO REMOVE IT. THEN TRIED THE TREPHINES OVER THE STEM AND STILL UNABLE TO FREE THE STEM. SO AN EXTENDED TROCHANTERIC OSTEOTOMY WAS PERFORMED, STRUT GRAFT AND THE LONGEST ACCORD TROCHANTERIC GRIP PLATE WAS USED OVER THE RESTORATION HIP SYSTEM WITH 9 CABLES IN TOTAL. THE LINER WAS NOT REPLACED.

  Patient problems: Injury

  MAUDE report 8206177 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE REVISION WAS PERFORMED DUE TO BREAKAGE OF THE PROXIMAL EMPERION STEM.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6833607 ↗
• InjuryJun 21, 2017Fracture; Fracture

  IT WAS REPORTED IN A PUBLICATION THAT A PATIENT HAD A REVISION DUE TO FRACTURE OF THE STEM. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 6656103 ↗