Oxford Uni Knee System 32-422805Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304525436), received between Jun 12, 2024 and Jun 9, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, WHILE TESTING DIFFERENT POLYETHYLENE (PE) THICKNESSES, REPEATED USE OF THE THICKNESS GAUGE AGAINST THE INTERNAL TIBIAL TEST GAUGE GENERATED PLASTIC DEBRIS. ALL DEBRIS WAS SUCCESSFULLY RETRIEVED FROM THE JOINT WITH NO HARM TO THE PATIENT OR DELAY TO THE PROCEDURE. THE SURGICAL TECHNIQUE WAS PROPERLY FOLLOWED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166071 ↗
• MalfunctionJul 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE WASHING THE INSTRUMENT IT WAS NOTICED THAT THERE IS A GROOVE IN THE GAUGE PROBABLY CAUSED BY THE TIBIAL PLATEAU. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/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 19836979 ↗
• MalfunctionJun 17, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546105 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC PADDLES ARE LEAVING BLUE DEBRIS. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE/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 19517779 ↗