Unitrax 6942-5-047Recalls & reported problems
Howmedica Osteonics Corp. · Head Component · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327032420), received between Jan 11, 2017 and Sep 9, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Insufficient Device Problem Information2
- Migration1
Patient problems
- Unspecified Infection4
- Injury3
- Joint Dislocation2
- Bone Fracture(s)1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION DUE TO INFECTION - REMOVAL OF HEAD & SLEEVE, WASH OUT.
Patient problems: Unspecified Infection
MAUDE report 23009704 ↗InjuryJan 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT REVISED, RIGHT SIDE, DUE TO DISLOCATION AND FRACTURE OF THE GREATER TROCHANTER. ALL COMPONENTS WERE REMOVED AND REVISED TO A CEMENTED STEM. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 18491098 ↗InjuryJul 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE UNIPOLAR HEAD FROM THE PATIENT'S NATIVE ACETABULUM. A 47MM UNIPOLAR HEAD AND +0 SLEEVE WERE REVISED TO A 46MM UNIPOLAR HEAD AND +8 SLEEVE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 17367404 ↗InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. A UNIPOLAR HEAD AND SLEEVE WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 14366334 ↗InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
AS NOTED ON A USAGE SHEET FOR REVISION OF PATIENT'S LEFT HIP: "REASON: POSSIBLE INFECTION. NO OTHER INFORMATION IS AVAILABLE DUE TO SEALED ELECTRONIC MEDICAL RECORDS." BRANCH PROVIDED THE PRIMARY AND REVISION USAGE SHEETS. A UNITRAX HEAD AND SLEEVE WERE REVISED.
Patient problems: Injury; Unspecified Infection
MAUDE report 9898066 ↗InjuryAug 29, 2018Migration; Migration
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO THE MIGRATION OF THE UNIPOLAR HEAD FROM THE ACETABULUM INTO THE PELVIS. PATIENT WAS REVISED TO A TOTAL HIP INCLUDING A TRIDENT SHELL, ADM/MDM LINER CONSTRUCT, AND A FEMORAL HEAD. STEM WAS WELL FIXED, WELL POSITIONED, AND WAS NOT REVISED.
Patient problems: Injury
MAUDE report 7826356 ↗InjuryJan 11, 2017Insufficient Device Problem Information
THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION.
Patient problems: Injury; Unspecified Infection
MAUDE report 6242991 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.