Scorpio 80-4409RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327030341), received between Apr 5, 2019 and Apr 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K042343); they may or may not involve this specific model.

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.

• InjuryApr 5, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND LOOSENING. ASEPTIC LOOSENING OF THE FEMORAL COMPONENT DUE TO OSTEOLYSIS. RIGHT TOTAL KNEE REVISION ARTHROPLASTY, FEMORAL COMPONENT AND TIBIAL LINER INSERT EXCHANGE WITH SYNOVECTOMY AND BONE GRAFTING OF A CONTAINED MEDIAL FEMORAL CONDYLAR DEFECT PERFORMED (B)(6) 2014. COMPONENTS USED IN REVISION: SCORPIO NRG #9 FEMUR WITH SIMPLEX P CEMENT AND 9X15 CR INSERT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8486689 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042343. One submission often covers many models, so check the product and lot details in each record.

• Z-1634-2015 · Aug 15, 2014 · Terminated
  Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of