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NA 129935Recalls & reported problems

Smith & Nephew, Inc. · UNIVERSAL FEMORAL HEAD 28MM +0 · 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 03596010087393), received between Dec 3, 2020 and Dec 3, 2020 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Failure of Implant1
  • Joint Dislocation1

Recent adverse event reports

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

  • InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, 30 YEARS AFTER THA SURGERY, THE IMPLANTS WERE MALPOSITIONED. PATIENT IS A CHRONIC DISLOCATOR AND IS ON HOSPICE. A REVISION SURGERY WAS PERFORMED AND THE FEMORAL HEAD WAS EXPLANTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Failure of Implant; Joint Dislocation

    MAUDE report 10939052 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

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