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BHR 74122556Recalls & reported problems

Smith & Nephew, Inc. · HEMI HEAD 56MM · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556071939), received between Feb 2, 2022 and Feb 2, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Biocompatibility1

Patient problems

  • Bone Fracture(s)1
  • Metal Related Pathology1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 2, 2022Biocompatibility; Biocompatibility

    USA LEGAL - IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2021 DUE TO TRUNNIONOSIS, INFLAMMATORY AND ADVERSE LOCAL SOFT TISSUE REACTION ASSOCIATED WITH METAL-ON-METAL BEARING OF HIP REPLACEMENT PROTHESIS AN RIGHT GREATER TROCHANTERIC DISPLACED FRACTURE (PATHOLOGIC TYPE-RELATED TO OSTEOLYSIS). THE PRIMARY RIGHT BHR THA SURGERY WAS PERFORMED ON (B)(6) 2009. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Bone Fracture(s); Metal Related Pathology

    MAUDE report 13423154 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.