UHR UH1-54-26Recalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327017243), received between Jan 17, 2017 and Jun 19, 2020 — classified as 3 injuries.
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
- Device Dislodged or Dislocated1
Patient problems
- Injury2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION OF THE BIPOLAR HEAD FROM THE PATIENT'S ACETABULUM. DUE TO THE PATIENT'S COMPLEX HISTORY , ALL IMPLANTS EXCEPT THE MODULAR DISTAL STEM WERE REMOVED AND A GIRDLESTONE PROCEDURE WAS PERFORMED. REP PROVIDED USAGE REPORTS FROM PRIOR REVISIONS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Injury
MAUDE report 10173170 ↗InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION WILL BE PERFORMED ON THE PATIENT'S HIP. AN IRRIGATION AND DEBRIDEMENT WITH REVISION OF THE BIPOLAR COMPONENT AND FEMORAL HEAD WILL BE PERFORMED ON (B)(6) 2020. THE REASON FOR THE REVISION WAS NOT REPORTED TO THE REP. REP PROVIDED THE USAGE SHEET FROM HER PREVIOUS SURGERY. THE REP MAY BE ABLE TO OBTAIN USAGE INFORMATION FOR THE UPCOMING REVISION. AS NO STRYKER REP WILL BE PRESENT FOR THE PROCEDURE, REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Injury
MAUDE report 9726799 ↗InjuryJan 17, 2017Insufficient Device Problem Information
IT WAS REPORTED PATIENT WITH HIP REPLACEMENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6256086 ↗
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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