BHR 74122538Recalls & reported problems
Smith & Nephew, Inc. · HEMI HEAD 38MM · Class 2 · Implant
All models of BHR (10)
Data updated Oct 16, 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 00885556071540), received between Mar 28, 2021 and Sep 6, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Biocompatibility1
Patient problems
- Metal Related Pathology3
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
- Insufficient Information1
- Nerve Damage1
- Osteolysis1
- Synovitis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2011, THE PATIENT UNDERWENT INTO A REVISION SURGERY, IN WHICH THE R3 38 MM ID US COCR LNR 50 MM AND THE HEMI HEAD 38 MM WERE EXPLANTED. IT IS UNKNOWN IF THERE WAS AN ADVERSE EVENT RELATED TO THE INITIAL SURGERY WHICH LED TO THE REVISION SURGERY. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information; Metal Related Pathology; Pain
MAUDE report 12431014 ↗InjuryMay 31, 2021Biocompatibility; Biocompatibility
*US LEGAL MDL* IT WAS REPORTED THAT, AFTER A THA METAL-ON-METAL CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF´S LEFT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED METALLOSIS CONSISTENT WITH FAILED METAL ON METAL HIP COMPONENTS. DUE TO SEVERE METALLOSIS, THE PLAINTIFF ALSO HAD A TROCHANTERIC FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE PLAINTIFF OUTCOME IS UNKNOWN.
Patient problems: Bone Fracture(s); Metal Related Pathology; Pain
MAUDE report 11910674 ↗InjuryMar 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
*US LEGAL* IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2020 DUE TO ELEVATED ION LEVELS AND METALLOSIS. THE CUP, LINER AND HEAD WERE REMOVED AND EXCHANGED WITH COMPETITOR DEVICES. THE STEM REMAINED IMPLANTED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Failure of Implant; Metal Related Pathology; Nerve Damage; Osteolysis; Synovitis
MAUDE report 11580483 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page