U2 Femoral component, PS 2103-3260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04712602345712), received between May 28, 2026 and May 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 18, 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.

• InjuryMay 28, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AN ADVERSE EVENT REGARDING THE FEMORAL COMPONENT WAS RECEIVED ON (B)(6) 2026. A 70-YEAR-OLD MALE PATIENT UNDERWENT RT. TKA SURGERY USING THE U2 TOTAL KNEE SYSTEM ON (B)(6) 2025. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION WITH REGULAR FOLLOW-UP. THE PATIENT HAS EXPERIENCED PAIN IN THE RIGHT KNEE JOINT SINCE (B)(6) 2026. THE TEST RESULTS OF THE JOINT ASPIRATE INDICATED STREPTOCOCCUS ANGINOSUS INFECTION, AND IMAGING STUDIES REVEALED A RADIOLUCENT LINE AROUND THE IMPLANT. DUE TO SEPTIC LOOSENING OF THE IMPLANT, DEBRIDEMENT AND REVISION SURGERY WERE PERFORMED ON (B)(6) 2026, FOLLOWED BY ANTIMICROBIAL THERAPY.

  Patient problems: Limb Pain; Medical device site infection

  MAUDE report 25313004 ↗

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