Oxford® Partial Knee System 154370Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05019279515646), received between Feb 2, 2022 and Feb 2, 2022 — classified as 1 injury.

1 FDA recall record name this device's identifier.

3 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.

Recalls naming this device

1. Apr 17, 2020Terminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2148-2020 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS APPROXIMATELY TWO (2) MONTHS FOLLOWING KNEE ARTHROPLASTY. FOLLOWING THE MANIPULATION, THE PATIENT'S RANGE OF MOTION IMPROVED AND THE PATIENT WAS ABLE TO RESUME REGULAR ACTIVITIES. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. MANIPULATION OPERATIVE NOTES NOTED THAT FLEXION MANIPULATION WAS PERFORMED AND CAREFUL BREAKING OF SCAR TISSUE ADHESIONS WAS AUDIBLE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13424838 ↗

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-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