Oxford Uni Knee System 32-422822Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05019279404445), received between Apr 15, 2021 and Feb 20, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT FEMORAL LINK DEVICE BROKE INSIDE INTRAMODULARY ROD DURING SURGERY. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. HOWEVER, NO PATIENT HARM OR FURTHER OUTCOME WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737034 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701566 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IM ROD LINK PIN FRACTURED WHILE REMOVING IT FROM THE IM ROD. THIS EVENT IS RELATED TO MALFUNCTION THAT COULD POTENTIALLY LEAD TO SERIOUS INJURY. 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 18118369 ↗
• MalfunctionAug 9, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487399 ↗
• MalfunctionJul 24, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377199 ↗
• MalfunctionJun 15, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135349 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361020 ↗
• MalfunctionAug 18, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE FIXATION PIN OF IM LINK ROD BROKE OFF DURING SURGERY. INSTRUMENT FAILURE WAS NOTED BY SURGEON ON REMOVAL OF DEVICE. ALL PIECES OF THE INSTRUMENT WERE LOCATED WITHIN IM ROD. THE INSTRUMENT BELONGED TO A LOAN OXFORD TRAIL CASE 2 TRAY. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335265 ↗
• MalfunctionAug 4, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING USE THE WING OF THE GUIDE BROKE AS IT WAS BEING MALLETED INTO THE ROD AND FEMORAL DRILL GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273067 ↗
• MalfunctionApr 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE ALIGNING FEMUR INSTRUMENTATION THE IM LINK BROKE IN IM GUIDE. NO HARM PATIENT OR DELAY IN SURGERY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671081 ↗