LPS 1987-16-217Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295078913), received between Jan 18, 2019 and Aug 6, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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

• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A INFECTED LEFT KNEE. LPS POLY INSERT WAS EXCHANGED. WASH OUT AND I&D WERE PERFORMED IT WAS REPORTED AT (B)(4). REVISED REPORT: PATIENT WENT ON TO HAVE A LEFT ABOVE KNEE AMPUTATION. ADDING IMPLANTS TO REPORT THAT WERE TAKEN OUT AT TIME OF AMPUTATION ON (B)(6) 2019. THESE WERE ORIGINALLY IMPLANTED (B)(6) 2019 AND (B)(6) 2019. DOI: (B)(6) 2019, (B)(6) 2019 AND (B)(6) 2019 (LPS UNIV TIB HIN INS XSM 16MM); DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8864561 ↗
• InjuryJan 18, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD FELL AND ALL THE COMPONENTS CAME LOOSE. THERE WAS LOOSENING OF THE FEMUR AT BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8261110 ↗