Scorpio 82-3-0512Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540364364), received between Mar 8, 2019 and Mar 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (K030978, K243817); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHEN THE SURGEON IMPACTED THE INSERT INTO TIBIAL TRAY, IT SUPPOSED TO SIT IN FLUSH AND WON'T BE ABLE TO LIFT BECAUSE IT IS LOCKED. SURGEON ABLE TO LIFT IT UP USING DISSECTOR WITH THE NEW REPLACEMENT UNIT. NO ISSUES WERE MENTIONED REGARDING THE BASEPLATE. THE 4TH INSERT WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407638 ↗
• MalfunctionMar 8, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT WHEN THE SURGEON IMPACTED THE INSERT INTO TIBIAL TRAY, IT SUPPOSED TO SIT IN FLUSH AND WON'T BE ABLE TO LIFT BECAUSE IT IS LOCKED. SURGEON ABLE TO LIFT IT UP USING DISSECTOR WITH THE NEW REPLACEMENT UNIT. NO ISSUES WERE MENTIONED REGARDING THE BASEPLATE. THE 4TH INSERT WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403632 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030978, K243817. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2026 · Jul 30, 2026 · Open, Classified
  SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyet
• Z-3197-2026 · Jul 30, 2026 · Open, Classified
  ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PAT
• Z-0899-2024 · Dec 1, 2023 · Open, Classified
  Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
• 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
• Z-0474-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral. # 4 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is
• Z-0473-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, #3 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-0472-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Left # 8; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized
• Z-0471-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Right # 7; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-0470-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is ut
• Z-0476-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, # 7 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is
• Z-0475-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, # 5 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07340. The Scorpio Femoral Components are a knee component that is utiliz
• Z-0477-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, #9 left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-1141-2010 · Aug 20, 2007 · Terminated
  Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ