EMPERION 71291302Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010561497), received between Jun 9, 2017 and Oct 13, 2021 — classified as 10 injuries.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON 2009, THE PATIENT EXPERIENCED SEVERE PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN ORDER TO SOLVE THIS ADVERSE EVENT. THE EMP 13 STEM PRIMARY HO WAS FOUND BROKEN JUST PROXIMAL TO THE SLEEVE. AN ETO WAS REQUIRED TO REMOVE THE STEM AND AN ACROSS STEM WAS IMPLANTED. IT IS UNKNOWN THE PATIENT CURRENT HEALTH STATUS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12624042 ↗
• InjuryFeb 28, 2021Break; Break

  IT WAS REPORTED THAT, A PATIENT HAD AN EMERSION 13 STEM PRIMARY HO IMPLANTED ON (B)(6) 2009. HOWEVER, THE PATIENT PRESENTED TO HOSPITAL WITH PAIN IN HIP, AND IT WAS FOUND THAT THE EMERSION STEM HAD SNAPPED IN HALF AT THE JUNCTION OF THE SLEEVE. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE OLD STEM WAS REMOVED THROUGH ETO AND OSTEOTOME BLADES, AND A REDAPT STEM WAS INSERTED. NO OPERATIVE REPORTS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Failure of Implant; Osteolysis; Pain

  MAUDE report 11390906 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A EMPERION STEM FRACTURE. INTRAOPERATIVELY IT WAS FOUND THAT THE PATIENT WAS INFECTED, ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 9315214 ↗
• InjuryNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A EMPERION STEM FRACTURE.

  Patient problems: Injury

  MAUDE report 9315212 ↗
• InjuryJul 28, 2019Break; Break

  IT WAS REPORTED THAT THE STEM BROKE INSIDE THE PATIENT. PATIENT COMPLAINED OF PAIN AND THE STEM WAS REVEALED TO BE BROKEN IN X-RAY. A REVISION SURGERY WAS PERFORMED DUE TO THIS INCIDENT.

  Patient problems: Pain

  MAUDE report 8834704 ↗
• InjuryMar 11, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN STEM.

  Patient problems: Injury

  MAUDE report 8410160 ↗
• InjuryOct 31, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF EMPERION FEMORAL STEM.

  Patient problems: Failure of Implant; Injury

  MAUDE report 8024781 ↗
• 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 7878448 ↗
• InjuryJun 20, 2017Fracture; Fracture

  IT WAS REPORTED IN A PUBLICATION THAT TWO PATIENTS UNDERWENT REVISION SURGERY DUE TO STEM FRACTURE.

  Patient problems: Injury

  MAUDE report 6655609 ↗
• InjuryJun 9, 2017Fracture; Fracture

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO BROKEN IMPLANT.

  Patient problems: Pain

  MAUDE report 6632471 ↗