Oxford Uni Knee System 32-422981Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05019279440023), received between Mar 26, 2021 and Sep 27, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823012 ↗
• InjuryJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BLUE PLUG DISASSEMBLED FROM THE INSTRUMENT. THE BLUE PLUG WAS FOUND AND DID NOT FALL INTO THE PATIENT. HOWEVER, POST OP X-RAYS CONFIRM THE METAL PIN THAT SECURES THE BLUE PLUG WAS RETAINED IN THE PATIENTS BODY. THE SURGEON TRIED TO REMOVE IT BY SCOPE WITH NO RESULT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17077178 ↗
• InjurySep 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: THAT THE POSTOPERATIVE X-RAY SHOWED THAT THERE WAS A FOREIGN BODY IN THE JOINT CAVITY AS RESULT OF THE PIN FROM THE INSTRUMENT DETACHING DURING THE PROCEDURE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE FOREIGN BODY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15355254 ↗
• MalfunctionJul 5, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY, THE LARGE PEG BROKEN OFF POSTERIOR FEMORAL CUTTER JIG INSTRUMENT CODE 32-422981 MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12115977 ↗
• MalfunctionMar 26, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING PIN IN THE OXFORD CUTTING GUIDE WAS LOST DURING SURGERY. A NEW PROCEDURE WAS REQUIRED TO REMOVE THE PIECE OF METAL FROM THE PATIENT'S KNEE WHICH WAS CARRIED OUT LATER THE SAME WEEK. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573796 ↗