UHR UH1-54-28Recalls & reported problems
Howmedica Osteonics Corp. · Bipolar Component · Class 2 · Implant
All models of UHR (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327017250), received between Aug 13, 2019 and Sep 4, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
- Device Dislodged or Dislocated1
Patient problems
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
BLACK STAINING OF UHR HEAD. UPDATE AUGUST 15TH; SPOKE TO REP. THIS WAS A PRIMARY SURGERY CASE FURTHER TO TRAUMA FOR A HIP FRACTURE WHERE THEY WERE IMPLANTING EXETER STEM AND UH1 HEAD INTO THE PATIENT. BLACK STAINING WAS NOTICED AND NOT USED. ANOTHER WAS USED INSTEAD. NO IMPACT TO PATIENT. THERE WAS NO REVISION FOR THIS PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8959554 ↗InjuryAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE BIPOLAR COMPONENT OUT OF THE PATIENT'S NATIVE ACETABULUM. THE PATIENT WAS CONVERTED FROM A HEMI HIP TO A TOTAL HIP. A SHELL, 5 SCREWS, CONSTRAINED LINER, AND A 28 +4 CERAMIC HEAD WERE IMPLANTED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE ORIGINAL FEMORAL HEAD. REP PROVIDED THE REVISION USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Injury
MAUDE report 8889025 ↗
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 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United 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 2515-3115United 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 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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