Oxford® Partial Knee System 154333Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05019279515189), received between May 18, 2023 and May 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K133940); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, THE NURSE OPENED THE PACKAGING AND NOTICED A HOLE IN THE FIRST PLASTIC LAYER. THE IMPLANT COULD NOT BE USED AS IT MAY HAVE NOT BEEN STERILE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952360 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133940. One submission often covers many models, so check the product and lot details in each record.

• Z-1018-2023 · Dec 15, 2022 · Open, Classified
  Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 15434
• Z-0624-2021 · Nov 25, 2020 · Terminated
  Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
• Z-2148-2020 · Apr 17, 2020 · Terminated
  Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cement
• Z-0956-2017 · Dec 6, 2016 · Terminated
  Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flu