UHR UH1-48-28Recalls & 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
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327017014), received between Nov 20, 2020 and Feb 18, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jul 30, 2026Class IIOpen, 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 · Recall details · FDA record ↗
- Jul 30, 2026Class IIOpen, 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-3197-2026 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Joint Dislocation2
- Joint Laxity1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED BY SALE REP THAT THERE IS A REVISION SURGERY PERFORMED DUE TO DISLOCATION, UHR BIPOLAR HEAD WAS DISLOCATED FROM INNER HEAD AFTER PRIMARY SURGERY PERFORMED (B)(6) 2023. REVISION DATE (B)(6) 2024
Patient problems: Joint Dislocation
MAUDE report 18728520 ↗InjuryAug 31, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
AS REPORTED: "TOTAL HIP ARTHROPLASTY REVISION - LEFT. DIAGNOSIS: UNSTABLE HEMI-ARTHROPLASTY. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A BIPOLAR COMPONENT AD FEMORAL HEAD WERE REVISED TO A TOTAL HIP.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 15325746 ↗InjuryNov 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. A UHR BIPOLAR COMPONENT AND C-TAPER LFIT HEAD WERE CONVERTED TO A TOTAL HIP. REP PROVIDED PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 10875900 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- "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
- V40 Head 6260-9-122Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall10 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 · each recall links to the FDA recall notice
- 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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