Anato 4845-7-216Recalls & reported problems
Howmedica Osteonics Corp. · NEUTRAL 130 Degree Neck Angle V40 Hip Stem · Class 2 · Implant
All models of Anato (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252631330), received between Dec 11, 2017 and Sep 22, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
- Scratched Material1
Patient problems
- Injury2
- Fall1
- Inadequate Osseointegration1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERIPROSTHETIC INFECTION; ACETABULAR COMPONENTS ARE NOTED TO BE COMPETITOR DEVICES.
Patient problems: Unspecified Infection
MAUDE report 23107182 ↗InjuryJan 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A RESTORATION MODULAR STEM CONSTRUCT, 32 +8 LFIT V40 HEAD, AND 3 DALL-MILES CABLE AND SLEEVE SETS WERE IMPLANTED. PATIENT FELL AND SUSTAINED A FEMORAL PERIPROSTHETIC FRACTURE. AN ANATO STEM AND STRYKER HEAD WERE REVISED.
Patient problems: Fall; Injury
MAUDE report 8272582 ↗InjuryDec 11, 2017Loss of Osseointegration; Device Dislodged or Dislocated; Scratched Material; Loss of Osseointegration; Device Dislodged or Dislocated; Scratched Material
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT REPORTED A DISLOCATION, SURGEON HAD PLANNED TO SWAP OUT LINER FOR MDM BUT WHILE REMOVING CERAMIC HEAD FROM STEM THE STEM CAME LOOSE. ALSO, SURGEON NOTICED A ROUGHENED ARTICULAR SURFACE ON THE POLY LINER AND THOUGHT IT WAS OUT OF THE ORDINARY.
Patient problems: Inadequate Osseointegration; Injury; Joint Dislocation
MAUDE report 7105078 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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