UHR UH1-56-26Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327017328), received between Jul 27, 2018 and Oct 28, 2019 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Contamination /Decontamination Problem1
Patient problems
- Injury2
- Pain2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT HAD SURGERY IN 2007 AND HIP BECAME PAINFUL AND NEEDED REVISION.
Patient problems: Injury; Pain
MAUDE report 9247363 ↗MalfunctionJul 1, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
PRIMARY PROCEDURE, RIGHT HEMI HIP. IT WAS REPORTED THAT ONCE THE IMPLANT WAS OPENED, WHAT APPEARED TO BE A HAIR WAS OBSERVED INSIDE THE CAVITY OF THE BIPOLAR HEAD ITSELF. DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT USED AND DISCARDED. ANOTHER DEVICE OF THE SAME CATALOG (DIFFERENT LOT) WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. THE REP PROVIDED A DEVICE PICTURE AND THE IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8748879 ↗InjuryJul 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO GROIN PAIN.
Patient problems: Injury; Pain
MAUDE report 7728751 ↗
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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