Orthinox 6364-2-126Recalls & 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
- 4
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540273314), received between Nov 13, 2018 and Nov 12, 2024 — classified as 1 death, 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
Patient problems
- Insufficient Information2
- Death1
- Injury1
- Thromboembolism1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem
PRIMARY SURGERY, ARTIFICIAL HEAD REPLACEMENT SURGERY, WAS PERFORMED 12 YEARS BEFORE. REVISION SURGERY WAS PERFORMED DUE TO A PROBLEM ON THE ACETABULAR SIDE. IT WAS FOUND THAT REMOVED STEM WITH BLACK STAIN ON MEDIAL PORTION OF STEM.
Patient problems: Insufficient Information
MAUDE report 20665618 ↗InjuryJun 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
FOR PI - REVISION OF A VITALOCK LINER IMPLANTED IN 2003 FOR POLY WEAR. DURING PROCEDURE SURGEON WAS SATISFIED THAT THE FEMUR AND ACETABULUM WERE WELL FIXED AFTER 17 YEARS, THEREFORE REPLACED ONLY THE LINER AND EXETER HEAD. THE OPPORTUNITY WAS TAKEN TO INCREASE THE HEAD SIZE TO 32MM ( FROM 26MM). CASE WENT SMOOTHLY. SURGEON WAS PLEASED WITH THE PERFORMANCE OF THE IMPLANT. HE SAID THE PATIENT WAS EXTREMELY ACTIVE AND ONLY AROUND 60 YEARS OLD WHEN HE HAD HIS THR. *NOTE- THERE IS NO OTHER INFORMATION AVAILABLE, AND THE SURGEON HAD NO COMPLAINT WITH THE DEVICE. PICKED UP ON XRAY AT ROUTINE FOLLOW UP.
Patient problems: Injury; Insufficient Information
MAUDE report 10151160 ↗InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2018, BHA WAS PERFORMED. ON (B)(6) 2019, PATIENT WAS DISCHARGED. LIGHT VTE WAS CONFIRMED. THIS EVENT HAS NO CAUSAL RELATIONSHIP WITH DEVICES.
Patient problems: Thromboembolism
MAUDE report 9696343 ↗DeathNov 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THIS CASE IS POST MKTG CLINICAL TRIAL FOR (B)(4). IT WAS RECEIVED THE CASE CARD. IT WAS MENTIONED AS UNK DEATH.
Patient problems: Death
MAUDE report 8066349 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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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