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Scorpio 77-4005Recalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer Tibial Tray · Class 2 · Implant

All models of Scorpio (107)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327029284), received between Mar 2, 2018 and Apr 5, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K994128); 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

Device problems

  • Device Operates Differently Than Expected1
  • Failure to Disconnect1
  • Material Distortion1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 5, 2018Failure to Disconnect; Failure to Disconnect

    IN ORDER TO USE STEM EXTENSION, KEEL END-CAP FOR THE SCORPIO TS TIBIAL IMPLANT NEEDED TO BE REMOVED BUT FAILED. ANOTHER BACK-UP IMPLANT WAS AVAILABLE. THE BACK-UP IMPLANT WAS OPENED AND USED IN THE SURGERY. SURGICAL DELAY TIME WAS APPR. 5-10 MIN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7400808 ↗
  • MalfunctionMar 2, 2018Device Operates Differently Than Expected; Material Distortion; Device Operates Differently Than Expected; Material Distortion

    THE SURGEON COULDN'T UNSCREW THE LOCKING SCREW ON THE SCORPIO TS TIBIAL TRAY FOR USING STEM EXTENSION, DURING THE SURGERY. SO, THE SURGEON CHANGED TO ANOTHER SCORPIO TS TIBIAL TRAY W/ DIFFERENT LOT NUMBER FOR SURGERY CLOSING. THERE WAS 5 ~ 10 MIN. DELAY OF SURGERY, DUE TO THE PROBLEM. LEFT KNEE.

    Patient problems: No Patient Involvement

    MAUDE report 7309198 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994128. One submission often covers many models, so check the product and lot details in each record.

  • Z-0877-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
  • Z-0879-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
  • Z-0882-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
  • Z-0876-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
  • Z-0881-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
  • Z-0880-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
  • Z-0875-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
  • Z-0878-2024 · Dec 1, 2023 · Open, Classified
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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