OSS™ Orthopedic Salvage System 161068Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304456136), received between Apr 28, 2021 and Dec 30, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• 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 21035659 ↗
• InjuryApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE LOCKING RING FRACTURE IS WHAT CAUSED THE YOKE TO DISASSOCIATE FROM THE TIBIAL TRAY. THEREFORE, THE LOCKING RING IS THE ONLY REPORTABLE ITEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11739339 ↗