EMPERION 71291301Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010561480), received between Apr 11, 2017 and Nov 12, 2021 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO THE FRACTURE OF AN EMP 13 STEM PRIMARY SO IMPLANTED 10 YEARS AGO AND REVISED TO A LONG STEM ECHELON. DURING THE SURGERY, THE EMP 13 STEM PRIMARY SO, THE EMP13 SLV SM CONE 1 SPOUT AND THE BIOLOX DELTA HEAD 36 MM 12/14 M / +4 WERE EXPLANTED. EXTENSIVE OSTEOTOMIES WERE PERFORMED DUE TO THE SIGNIFICANT INGROWTH OF BONE ONTO PROXIMAL SLEEVE. MOREOVER, THE SHELL AND THE CERAMIC LINER WERE LEFT UNTOUCHED. THE EXPLANTED DEVICES ARE NOT ABLE TO BE EVALUATED. NO FURTHER INFORMATION AVAILABLE REGARDING THE POST OPERATIVE CONDITION OF PATIENT IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12804686 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN EMPERION STEM FAILURE. THE SURGEON APPLIED A BENDING FORCE AS WOULD BE PRESENT WITH WEIGHTBEARING AND FELT THAT HE COULD SEE A SMALL AMOUNT OF GAPPING AND OPENING AT THE LATERAL ASPECT OF THE STEM CONSISTENT WITH A FATIGUE FAILURE.

  Patient problems: Injury

  MAUDE report 9633877 ↗
• InjuryJun 2, 2018Fracture; Fracture

  DR REVISED AN EMPERION STEM THAT HAD BEEN IMPLANTED APPROXIMATELY 9 YEARS AGO; THE STEM HAD FRACTURED INSIDE THE TOP OF THE CONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 7564010 ↗
• InjuryJun 21, 2017Fracture; Fracture

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

  Patient problems: Injury

  MAUDE report 6656102 ↗
• InjuryApr 11, 2017Mechanical Problem; Unstable; Device Operates Differently Than Expected

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF LEFT THA DUE TO MECHANICAL FAILURE OF THE IMPLANT, AS REPORTED DUE TO ROTARY INSTABILITY OF FEMORAL COMPONENT AT THE MOSE STEM/SLEEVE JUNCTION. ALL COMPONENTS EXCEPT FOR ACETABULAR SHELL WERE REVISED.

  Patient problems: Failure of Implant; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 6479562 ↗