OSS™ Orthopedic Salvage System 161073Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304456181), received between Apr 28, 2021 and Dec 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION. THREE MONTHS POSTOP, THE PATIENT REPORTED FALLING AND RUPTURED THE MEDIAL RETINACULAR AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT TO ENSURE THERE WAS NO INFECTION AND THE CAPSULE WAS NOT DAMAGED. NO IMPLANTS WERE EXCHANGED. SIX MONTHS AFTER THE FALL, THE PATIENT REPORTS SHE WOKE UP AND HYPEREXTENDED HER KNEE RESULTING IN PAIN AND THE INABILITY TO BEAR WEIGHT. X-RAY IMAGES SHOWED METAL FRAGMENTS FROM THE LOCKING RING AND POLY FRAGMENTS IN THE JOINT. THE PATIENT WAS REVISED ONE MONTH LATER IN WHICH THE METAL AND POLY HINGE MECHANISMS WERE REPLACED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall; Hyperextension; Muscle/Tendon Damage; Pain; Subluxation

  MAUDE report 21035705 ↗
• InjuryNov 7, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 20629816 ↗
• InjuryApr 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE MONTHS¿ POST-IMPLANTATION DUE TO LOCKING NUT FRACTURED IN TWO PIECES AND ALLOWED PISTON TO DISENGAGE FROM THE TIBIAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11739283 ↗