U2 Tibial insert, PS 2303-3031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04712602348102), received between Apr 10, 2026 and Apr 10, 2026 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K051640); 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.

• MalfunctionApr 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH IMPLANTATION OF A FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, AND PATELLAR COMPONENT. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED IN IMPROVED CONDITION WITH ROUTINE FOLLOW-UP. POSTOPERATIVELY, THE PATIENT HAD ACCEPTABLE RANGE OF MOTION BUT EXPERIENCED INTERMITTENT PAIN. JOINT ASPIRATION CONFIRMED STREPTOCOCCUS AGALACTIAE INFECTION, AND IMAGING SHOWED A RADIOLUCENT LINE AROUND THE PROSTHESIS, CONSISTENT WITH PROSTHETIC JOINT INFECTION AND LOOSENING. ON (B)(6) 2025, THE PATIENT WAS ADMITTED DUE TO POSTOPERATIVE WOUND INFECTION AND UNDERWENT DEBRIDEMENT AND REVISION SURGERY, FOLLOWED BY ANTI-INFECTIVE TREATMENT.

  Patient problems: Local Reaction

  MAUDE report 24841649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051640. One submission often covers many models, so check the product and lot details in each record.

• Z-1128-2018 · Nov 24, 2017 · Terminated
  U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or rel