Orthinox 6364-2-028Recalls & reported problems
Howmedica Osteonics Corp. · V40 FEM HEAD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540273277), received between Aug 6, 2019 and Aug 6, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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.
Most reported problems
Device problems
- Degraded1
- Insufficient Device Problem Information1
Patient problems
- Ambulation or Postural Difficulties1
- Fall1
- Inflammation1
- Injury1
- Pain1
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information
PATIENT PRESENTED COMPLAINING ABOUT PAIN IN FEMUR SOMETIME AFTER A FALL , SO X RAYS WERE TAKEN AND IT APPEARED TO HAVE ¿VOID BUBBLES¿ AKIN TO LYSIS/INFECTION/ METALOSIS ETC AROUND THE IMPLANT AND CEMENT MANTLE SO THE SURGEON DECIDED TO REVISE IT. THE RESULTS FROM THE 2X SPECIMENS TAKEN FROM THE HIP CAPSULE DURING THE REVISION PROCEDURE: ONE HAD NO SIGN OF ABNORMALITY HOWEVER THE OTHER SHOWED ¿CLUSTERS OF POLY MORPH IN BLACK METALOSIS¿. DR LANE DECIDED TO DO A 1ST STAGE REVISION WITH A ¿KIWI SPACER¿. THR DONE APPROXIMATELY 15 YEARS AGO (WITH EXETER/ TRIDENT THR). LEFT SIDE.
Patient problems: Ambulation or Postural Difficulties; Fall; Inflammation; Injury; Pain; Reaction
MAUDE report 8866551 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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