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OXINIUM 71342288Recalls & reported problems

Smith & Nephew, Inc. · OXINIUM FEMORAL HEAD 14/16 TAPER 28MM +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 03596010502254), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1

Patient problems

  • Joint Laxity1

Recent adverse event reports

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

  • InjuryJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2020 THE PATIENT EXPERIENCED DISLOCATION OF THE HEAD FROM AN ANTHOLOGY STEM. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE OXI FM HEAD 14/16 TPR 28 +8. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Patient problems: Joint Laxity

    MAUDE report 14718192 ↗

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.