OSS™ Orthopedic Salvage System 161094Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304467989), received between Jul 20, 2022 and Jun 11, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND WAS SUBSEQUENTLY REVISED DUE TO A PERIPROSTHETIC FRACTURE FOLLOWING A FALL AND NEW COMPONENT WERE IMPLANTED. THE PATIENT DID WELL UNTIL DEVELOPING SLIGHT RECURVATUM WITH KNEE EXTENSION BEYOND NEUTRAL. THE PATIENT THEN UNDERWENT A POLYETHYLENE INSERT EXCHANGE, AND INTRA-OPERATIVELY THE BEARING WAS OBSERVED TO BE CRACKED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hyperextension

  MAUDE report 25471043 ↗
• InjuryNov 11, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

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

  Patient problems: Failure of Implant

  MAUDE report 20652376 ↗
• InjuryAug 3, 2023Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH LEFT KNEE PAIN AND INSTABILITY APPROXIMATELY FIVE YEARS POSTOP AND UNDERWENT A REVISION SURGERY. THE BEARING AND BUSHING KIT WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Pain

  MAUDE report 17452225 ↗
• InjuryJul 20, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS IMPLANT BREAKAGE POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Failure of Implant; Hyperextension; Pain

  MAUDE report 15064294 ↗