Scorpio 72-4-0316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327034325), received between Apr 12, 2017 and Apr 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Falling” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K243817, 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2017Detachment Of Device Component; Component Falling; Device Slipped; Fitting Problem; Detachment Of Device Component; Fitting Problem

  METAL LOCKING RIM ON POLY DID NOT ENGAGE AND FELL UPON IMPACTION. THE SURGEON DESCRIBED THE POLY AS 'FALLING IN' INSTEAD OF CLIPPING AND LOCKING IN. UNABLE TO USE LINER AND WAS UNABLE TO COMPLETE A LINER CHANGE DURING THIS STAGE OF A WASHOUT. THE PATIENT WAS COMING BACK TO THEATRE FOR ANOTHER WASHOUT IN 3 DAYS TIME. THE SURGEON WILL COMPLETE THE CHANGE THEN.

  Patient problems: Fall; No Known Impact Or Consequence To Patient

  MAUDE report 6487708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243817, K994128. One submission often covers many models, so check the product and lot details in each record.

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