OXINIUM 71341909Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556112519), received between Dec 28, 2017 and Nov 3, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2020Adverse 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 DISASSOCIATION ON (B)(6) 2020. IT WAS REVEALED THE RING OF BIPOLAR WAS LEFT IN THE DEVICE. PROBLEM WAS FOUND OUT ON (B)(6) 2020. THE OUTCOME OF THE PATIENT IS UNKNOWN. INVESTIGATION TEAM INDICATED THAT A SECOND DEVICE WAS RETURNED (OXINIUM HD 10/12 26MM -5 EXT) WITH THE FIRST ONE REPORTED, THIS HAD NOT BEEN REPORTED PREVIOUSLY TO US. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Insufficient Information; Joint Dislocation

  MAUDE report 10782320 ↗
• InjuryDec 28, 2017Adverse 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 DISLOCATION AND PAIN.

  Patient problems: Joint Dislocation

  MAUDE report 7152220 ↗