UHR UH1-44-26Recalls & reported problems
Howmedica Osteonics Corp. · Bipolar Component · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327016888), received between Nov 9, 2017 and Nov 12, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3199-2026 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated5
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Injury4
- Joint Dislocation4
- Hematoma1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS OF THE BIPOLAR COMPONENT FROM THE PATIENT'S NATIVE ACETABULUM. THE HIP WAS CONVERTED TO A TOTAL HIP (STEM WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 23536384 ↗InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HEMI HIP WAS REVISED DUE TO SUSPECTED INFECTION. A BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 18884448 ↗InjuryOct 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE BIPOLAR COMPONENT FROM THE PATIENT'S NATIVE ACETABULUM. THE BIPOLAR COMPONENT AND HEAD WERE REVISED TO A TOTAL HIP. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. BRANCH PROVIDED THE PRIMARY USAGE SHEET, AND REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Dislocation
MAUDE report 10709898 ↗InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEMATOMA WITH NO ACUTE INFLAMMATION. AN IRRIGATION AND DEBRIDEMENT WITH WASHOUT AND EXCHANGE OF THE FEMORAL HEAD AND BIPOLAR COMPONENT WERE PERFORMED. PATIENT WAS REVISED TO DEVICES OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Hematoma; Injury
MAUDE report 8821678 ↗InjuryAug 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER MULTIPLE DISLOCATIONS. AS REPORTED BY REP: "BIPOLAR COMPONENT AND FEMORAL HEAD COMPONENT WERE RE-SIZED AND SWAPPED OUT". PATIENT REVISED FROM A 26 +0 METAL HEAD AND 44MM BIPOLAR COMPONENT TO 26 +4 METAL HEAD AND 43MM BIPOLAR COMPONENT. BIPOLAR/ HEAD CONSTRUCT DISLOCATED FROM PATIENT'S NATIVE ACETABULUM.
Patient problems: Injury; Joint Dislocation
MAUDE report 7754514 ↗InjuryApr 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION.
Patient problems: Injury; Joint Dislocation
MAUDE report 7443317 ↗InjuryNov 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED FROM A HEMI ARTHROPLASTY TO A THR. PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION OF THE HEAD FROM THE BIPOLAR COMPONENT.
Patient problems: Injury
MAUDE report 7014399 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
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- "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.