OXINIUM 71341916Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556112465), received between May 22, 2017 and Aug 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED 14 YEARS AGO AND THE PATIENT EXPERIENCED SUBLUXATIONS 3 TIMES. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO REPLACE THE CUP (MANUFACTURED BY ANOTHER COMPANY) AND HEAD (MANUFACTURED BY S+N), BUT THE SUBLUXATION WAS NOT STILL RESOLVED. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACED THE CUP (MANUFACTURED BY ANOTHER COMPANY) AND THE OXONIUM HD 10/12 28 MM +5 EXT (MANUFACTURED BY S+N). IT WAS NOTICED THAT THE DEVICE WAS HEAVILY DAMAGED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Subluxation

  MAUDE report 12387709 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Injury

  MAUDE report 8604091 ↗
• InjuryMay 22, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION.

  Patient problems: Failure of Implant; Joint Dislocation; No Code Available

  MAUDE report 6580906 ↗