Avenir® 01.06010.105 (UDI 00889024591004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024591004), received between Feb 1, 2022 and Apr 28, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.

• MalfunctionApr 28, 2026Difficult to Insert; Peeled/Delaminated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY TOTAL HIP ARTHROPLASTY. DURING THE PROCEDURE, THE SURGERY ATTEMPTED TO FURTHER ADVANCE THE FEMORAL STEM TO CORRECT EXCESSIVE LEG LENGTHENING WHICH RESULTED IN A FISSURE OF THE FEMORAL SHAFT. THE STEM WAS REMOVED, AND CERCLAGE CABLES WERE PLACED AROUND THE SHAFT. UPON INSPECTION OF THE EXPLANTED STEM, THE SURGEON NOTED DAMAGE TO THE STEM COATING; THEREFORE, A NEW STEM OF THE SAME SIZE WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 25021654 ↗
• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY FIVE (5) YEARS AGO. ABOUT THREE (3) YEARS LATER THE PATIENT HAD A LOW ENERGY 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 17341276 ↗
• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY FIVE (5) YEARS AGO. ABOUT FOUR (4) YEARS LATER PATIENT HAD A LOW ENERGY 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 17341262 ↗
• InjuryJun 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP PROSTHESES IMPLANTATION APPROXIMATELY TEN (10) YEARS AGO. ABOUT NINE (9) YEARS LATER, BY SITTING ON A BENCH THAT COLLAPSED, PATIENT FELL TO THE GROUND AND SUSTAINED A B2 PERIPROSTETIC 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); Failure of Implant; Fall

  MAUDE report 17223945 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION DUE TO INFECTION (DEEP INFECTION).

  Patient problems: Post Operative Wound Infection

  MAUDE report 13413648 ↗