LPS 1987-15-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295078746), received between Sep 12, 2025 and Jun 15, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: AUGUST 10, 2023. DOR: MAY 20, 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25503648 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: FEMORAL COMPONENT AND TIBIAL INSERT WERE FUNCTIONING NORMALLY AT THE TIME OF REMOVAL.

  Patient problems: Pain

  MAUDE report 23036190 ↗