Avenir® 01.06010.104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024590984), received between Dec 2, 2021 and Jul 18, 2023 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY FOUR AND HALF (4,5) YEARS AGO. ABOUT THREE AND HALF (3,5) YEARS LATER PATIENT HAD A DOMESTIC FALL AND SUSTAINED A B2 PERIPROSTHETIC FRACTURE.THE PATIENT UNDERWENT REVISION OF THE FEMORAL COMPONENT. THERE WAS MINIMAL BONE INGROWTH ON THE REMOVED STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17341279 ↗
• InjuryDec 2, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL OVER AND SUSTAINED A LEFT FEMORAL FRACTURE, BELOW THE GREATER TROCHANTER DOWN AROUND THE IN SITU STEM IN THE PROXIMAL THIRD OF THE FEMUR. THERE WAS NO OBVIOUS PROBLEMS LIKE INSTABILITY OR LOOSENING BEFORE THE FALL. THE SURGEON DOES NOT BLAME THE PROSTHESES FOR THE FALL. THE AVENIR STEM WAS REMOVED AND AN ARCOS STEM INSERTED. PATIENT OUTCOME- REVISION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12915052 ↗