Oxford Uni Knee System 32-422760Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304525658), received between Jul 1, 2019 and Jan 13, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS USING THE HAMMER TO IMPACT A COMPONENT WHEN IT BROKE IN 2 PIECES. NOTHING FELL IN THE PATIENT AND A BACKUP WAS AVAILABLE. NO DELAY. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139803 ↗
• InjuryFeb 22, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED, THAT: THE HEAD OF THE TOFFEE HAMMER BROKE AWAY FROM THE HANDLE. THE DOCTOR USED THE HOSPITAL HAMMER TO COMPLETE ANY FURTHER HAMMERING. NO DELAY - NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576309 ↗
• MalfunctionFeb 9, 2022Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: THE DR. WAS IMPACTING THE FEMUR AND THE TOFFEE HAMMER BROKE. THERE WAS NO HARM TO THE PATIENT OR DELAY IN THE CASE ANOTHER HAMMER WAS USED TO FINISH THE CASE. PATIENT INVOLVEMENT- NO FURTHER OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497245 ↗
• MalfunctionDec 1, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: THE NURSE OPENED THE OXFORD TRAY FOR SURGERY AND REALISED THE HAMMER WAS BROKEN INTO 2 PIECES. NO PATIENT INVOLVEMENT. ADDI 20 JAN 2022. PICTURE OF THE ITEM RECEIVED. NO LOT NUMBER VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907946 ↗
• MalfunctionNov 29, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE HAMMER HAS BROKEN IN HALF WHILE IMPACTING THE FEMORAL TRIAL.NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882348 ↗
• MalfunctionMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PRODUCT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830778 ↗
• MalfunctionFeb 12, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE IMPACTION OF A TRIAL ON RIGHT KNEE, THE UNI TOFFEE HAMMER BROKE IN HALF. NOTHING FELL INTO THE PATIENT AND NO HARM WAS DONE TO THE PATIENT EITHER. THEY WERE ABLE TO FINISH THE SURGERY WITH ANOTHER SMALL HAMMER WITH NO PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699329 ↗
• MalfunctionOct 2, 2019Break; Break

  IT WAS REPORTED BY THE HOSPITAL THAT DURING SURGERY, OXF UNI TOFFEE HAMMER BROKE DUE TO NORMAL USE. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH ANOTHER HAMMER. IT'S ALSO REPORTED THAT THE HAMMER WAS USED APPROXIMATELY 20 TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144092 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT A TOFFEE HAMMER BROKE WHILE IMPACTING TRIAL IMPLANTS.

  Patient problems: No Information

  MAUDE report 8747984 ↗