Oxford Partial Knee System 32-422698Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05019279346608), received between Jul 13, 2020 and Jul 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

22 other recalls cover devices cleared under the same FDA submission (P010014); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THAT DURING THE SURGERY THE SURGEON WAS TRIALING AND WHEN HE REMOVED THE TRIAL BEARING A SMALL PART OF IT CHIPPED. NO DELAY OR REPORTED HEALTH CONSEQUENCES TO PATIENT. 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 14942193 ↗
• MalfunctionMar 16, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED, THAT: THE SURGEON WAS TRIALLING AND WHEN SHE REMOVED IT BROKE. SHE FOUND ALL THE PIECES AND MADE SURE NO PIECES WERE LEFT, INPATIENT. DELAY: 5 MIN. PATIENT OUTCOME: PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789249 ↗
• MalfunctionJul 13, 2020Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE SURGEON APPLIED THE BIOLOGICAL FEMORAL CONDYLE IMPLANTS AND THE CEMENT PLATFORM IMPLANTS, PRESSURISED THE PROSTHESIS WITH A SMALL 3MM GASKET AND TESTED THE FLEXION AND EXTENSION BALANCE. AFTER THAT, THE OXFORD TRIAL BEARING W/SLOTS WAS REMOVED WITH A HANDLE, AND THE OXFORD TRIAL BEARING W/SLOTS WAS FOUND TO BE BROKEN WHEN PLACED ON THE OPERATING TABLE. DELAY OF SURGERY: 20 MINUTES.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 10263456 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010014. One submission often covers many models, so check the product and lot details in each record.

• Z-1172-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1158-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1157-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1170-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1165-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
• Z-1169-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1153-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1161-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1162-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1155-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1159-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1171-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1154-2017 · Jan 5, 2016 · Terminated
  Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1160-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
• Z-1156-2017 · Jan 5, 2016 · Terminated
  Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

…and 7 more.