OXFORD UNICOMPARTMENTAL KNEE PHASE 3TRIAL FEMORAL REMOVER 32-420126Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05019279477234), received between Mar 4, 2022 and Dec 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SLAP HAMMER SPRING MECHANISM BROKE. THERE WAS NO IMPACT TO THE PATIENT AND NO DELAY. 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 23835987 ↗
• MalfunctionSep 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE CLAMPING MECHANISM DOESN'T HOLD THE BROACH ONTO THE HANDLE DURING THE PRODUCT EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199673 ↗
• MalfunctionDec 20, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362446 ↗
• MalfunctionApr 7, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16701405 ↗
• MalfunctionMar 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ELEMENT ON THE TIP OF THE INSTRUMENT WAS FRACTURED. 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 16458485 ↗
• MalfunctionMar 4, 2022Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: THE OPERATION WAS PERFORMED WITH THE OXFORD SYSTEM ON (B)(6) 2022. DURING THE PROCEDURE, THE SPRING THAT IS HOOKED TO THE CLAW ON THE TIP OF THE REMOVER WAS BROKEN. THE BROKEN PIECE WAS LOST, BUT THE POSTOPERATIVE X-RAY SHOWED A METAL FRAGMENT. PATIENT INVOLVEMENT- FURTHER OUTCOME UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13665711 ↗