OSS™ Orthopedic Salvage System 161095Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304481138), received between Aug 24, 2023 and Nov 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 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.

• InjuryNov 14, 2025Fracture; Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem; Fracture; Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS EXCESSIVE HYPEREXTENSION AND INSTABILITY APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. DURING THE REVISION, THE FEMORAL BUSHINGS AND POLYETHYLENE TIBIAL BEARING WERE IDENTIFIED TO HAVE FRACTURED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hyperextension

  MAUDE report 23555784 ↗
• InjuryAug 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY 2.5 YEARS LATER. ONLY THE POLY WAS REVISED AND THE SURGEON NOTED THAT THE PATIENT REQUESTED THE REVISION AND THAT THERE WAS NO MAJOR DAMAGE TO THE BEARING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17614129 ↗