OXFORD UNICOMPARTMENTAL KNEE PHASE 3SPHERICAL CUTTER 32-420330Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05019279482283), received between Jul 5, 2021 and Sep 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 6, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT AFTER THE STERILIZATION PROCESS, THE INSTRUMENT BECAME DISCOLOURED AND IS NOT SUITABLE FOR REPROCESSING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688894 ↗
• MalfunctionJul 5, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, IT WAS IDENTIFIED THAT THE BONE MILL WAS NOT SHARP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12115321 ↗