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OXINIUM 71341940Recalls & reported problems

Smith & Nephew, Inc. · OXINIUM FEMORAL HEAD 10/12 32MM +0 EXTENSION · Class 2 · Implant

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556112441), received between Oct 24, 2017 and Sep 1, 2021 — classified as 4 injuries, 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem2
  • Device Dislodged or Dislocated1
  • Insufficient Device Problem Information1
  • Material Separation1

Patient problems

  • Joint Dislocation2
  • Injury1
  • No Consequences Or Impact To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE SURGEON SAID THAT THE DEVICES WERE NOT DEFECTIVE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Joint Dislocation

    MAUDE report 12410624 ↗
  • InjuryOct 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    AFTER SEVERAL DISLOCATIONS AND A POLY EXCHANGE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2019.

    Patient problems: Joint Dislocation

    MAUDE report 9222234 ↗
  • MalfunctionAug 22, 2019Material Separation; Material Separation

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE FEMORAL HEAD WAS EXCHANGED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8920516 ↗
  • InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE PRODUCT WAS DISPOSED.

    Patient problems: Unspecified Infection

    MAUDE report 7180674 ↗
  • InjuryOct 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PATIENT HAS MENTAL DISEASE AND WAS OUT OF CONTROL. SO THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE. THE PRODUCTS WERE DISPOSED AFTER THE SURGERY SO IT CANNOT BE RETURNED.

    Patient problems: Injury

    MAUDE report 6973369 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

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