Skip to content

OXINIUM 71342368Recalls & reported problems

Smith & Nephew, Inc. · OXINIUM FEMORAL HEAD 14/16 TAPER 36MM +8 NECK · 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 03596010502285), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Discomfort1
  • Implant Pain1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryJun 10, 2022Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

    IT WAS REPORTED THAT, AFTER A THR CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S HIP ON (B)(6) 2021, THE PATIENT SUSTAINED UNSPECIFIED SYMPTOMS. THE SURGEON DISCOVERED AN INCOMPATIBILITY ISSUE BETWEEN THE FEMORAL HEAD AND NECK IMPLANT, FOR WHICH HE ADVISED THAT A REVISION SURGERY WAS NECESSARY. THIS INTERVENTION WAS PERFORMED ON (B)(6) 2022.

    Patient problems: Discomfort; Implant Pain; Insufficient Information

    MAUDE report 14655130 ↗

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.