LPS 1987-16-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295078906), received between Oct 12, 2022 and Oct 12, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER KNEE REVISED APPROXIMATELY 3 YEARS AGO WHERE HER FEMORAL COMPONENT AND STEM WERE EXPLANTED AND REPLACED WITH A LPS DISTAL FEMORAL COMPONENT, A SEGMENT, AND A POROUS COATED STEM. THIS CONSTRUCT BECAME LOOSE OVER TIME, BOTH DECIDED TO REVISE THE CONSTRUCT AND REPLACE WITH A NEW DISTAL FEMORAL COMPONENT, A NEW SEGMENT, AND A NEW CEMENTED BOWED STEM. UNFORTUNATELY THE SALES REP DID NOT HAVE THE OP NOTES WITH THIS PATIENT'S REVISION HISTORY, PATIENT DEMOGRAPHIC INFORMATION, AND SOME OF THE EXPLANTED IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15586695 ↗