OXINIUM 71342208Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010488886), received between Dec 1, 2017 and Jan 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED IN 2023, THE PATIENT EXPERIENCED HIP DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE OXINIUM FEM HD 12/14 22 MM +8 WAS EXPLANTED AND THE LINER REMAINED AS IT LOOKED INTACT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 21094692 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT HAD ANOTHER DISLOCATION (IT WAS STATED THAT THE PATIENT WAS NON-COMPLIANT). A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE 43 MM CEMENTED POLARCUP (B)(4), THE 43 MM XLPE INSERT 43 MM/22 MM (B)(4) AND THE OXONIUM HEAD 22 MM +8 MM (B)(4). THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 11812656 ↗
• InjuryApr 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS IS 3RD REVISION OF HIP (PREVIOUS PRODUCT EXPERIENCE). PATIENT DISLOCATED HIP.

  Patient problems: Injury

  MAUDE report 8485273 ↗
• InjuryMar 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS IS 3RD REVISION OF HIP (PREVIOUS PRODUCT EXPERIENCE). PATIENT DISLOCATED HIP.

  Patient problems: Injury

  MAUDE report 8453225 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY DUE TO MULTIPLE DISLOCATIONS FOLLOWING PRIMARY HIP ARTHROPLASTY. SURGEON FOUND R3 CUP STABLE AND WELL FIXED.

  Patient problems: Joint Dislocation

  MAUDE report 7281021 ↗
• InjuryDec 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS PUTTING ON CLOTHES AND DISLOCATED. THIS WAS ORIGINALLY PUT IN (B)(6) 2017. HE SAID THE CUP WAS ABOUT 15 DEGREES RETROVERTED AND SLIGHTLY VERTICAL. HE ALSO SAID HE HAS NEVER SEEN A HEAD COME OUT OF A CONSTRAINED LINER WITHOUT CATASTROPHIC FAILURE, WHICH THIS DID NOT HAVE, MEANING LINER BECAME DISLODGED OR SCREW AND CUP PULL OUT.

  Patient problems: Joint Dislocation

  MAUDE report 7077049 ↗