Anato 4845-7-104Recalls & reported problems
Howmedica Osteonics Corp. · ANTEVERTED 130 Degree Neck Angle V40 Hip Stem · Class 2 · Implant
All models of Anato (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252631095), received between May 5, 2021 and May 6, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. A HEMI HIP CONSISTING OF AN ANATO STEM, UHR BIPOLAR COMPONENT, AND 26 -3 V40 LFIT HEAD WERE REVISED TO A TOTAL HIP. WHILE REMOVING THE ANATO STEM, AN INTRA-OPERATIVE FEMORAL FRACTURE OCCURRED AND WAS TREATED WITH 2 CABLES FROM HOSPITAL INVENTORY AND IMPLANTING A RESTORATION MODULAR STEM CONSTRUCT. WHILE IMPLANTING A 48MM SHELL, THE SHELL PASSED THROUGH THE PATIENT'S ACETABULUM (SURGEON REPORTED THIS WAS DUE TO POOR BONE QUALITY). THE SURGEON WENT TO A 50 MULTIHOLE SHELL WITH 4 SCREWS. THE SCREWS DIDN'T PROVIDE ADEQUATE FIXATION IN THE SURGEON'S OPINION (DUE TO THE PATIENT'S POOR BONE QUALITY), SO THE 50MM SHELL WAS CEMENTED IN INSTEAD. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 11784571 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI IS FOR THE INTRA-OPERATIVE EVENTS THAT OCCURRED DURING THE REVISION SURGERY: WHILE REMOVING THE ANATO STEM, AN INTRA-OPERATIVE FEMORAL FRACTURE OCCURRED AND WAS TREATED WITH 2 CABLES FROM HOSPITAL INVENTORY AND IMPLANTING A RESTORATION MODULAR STEM CONSTRUCT. WHILE IMPLANTING A 48MM SHELL, THE SHELL PASSED THROUGH THE PATIENT'S ACETABULUM (SURGEON REPORTED THIS WAS DUE TO POOR BONE QUALITY). THE SURGEON WENT TO A 50 MULTIHOLE SHELL WITH 4 SCREWS. THE SCREWS DIDN'T PROVIDE ADEQUATE FIXATION IN THE SURGEON'S OPINION (DUE TO THE PATIENT'S POOR BONE QUALITY), SO THE 50MM SHELL WAS CEMENTED IN INSTEAD. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 11776021 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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