Scorpio 76-4109RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327029208), received between Oct 21, 2025 and Oct 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryOct 21, 2025Fracture; Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE 2025 REVISION. AS PER PSS IMPLANT REQUEST CASE (B)(4): FAILED RIGHT KNEE TOTAL KNEE WITH BROKEN COMPONENTS; MORBID OBESITY WITH BMI GREATER THAN 44. THIS PATIENT HAS A # 9 SCORPIO TS FEMORAL COMPONENT WITH A 23X80 STEM EXTENDER. THERE IS A FRACTURE OF THE IMPLANT AT THE STEM FEMORAL JUNCTION. THE PATIENT HAS A #13 SCORPIO TIBIAL TRAY WITH 10MM AUGMENTS MEDIAL AND LATERAL AND A 16X80 STEM EXTENDER. ALSO IMPLANTED IN TIBIA IS A 59MM TRABECULAR METAL CONE (ZIMMER). CURRENTLY A SIZE 11 8MM SCORPIO PS TIBIAL BEARING IS IMPLANTED. NEEDED FOR THIS NEXT REVISION IS AN INSERT (PS OR TS) TO MATE WITH A TRIATHLON TS FEMORAL COMPONENT. THE SURGEON NEED TO LEAVE THE CURRENT TIBIAL CONSTRUCT IMPLANTED. PATIENT HAS HAD SEVERAL KNEE REVISIONS. 2005 BOTH COMPONENTS REVISED, 2006 TIBIAL INSERT REVISED, 2014 THE TIBIAL TRAY AND INSERT REVISED.

  Patient problems: Insufficient Information

  MAUDE report 23346346 ↗

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-0878-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
• 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-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-0882-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
• 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