Scorpio 76-4105RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327029185), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

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

• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. RECORDS FROM A PREVIOUS REVISION, COMPARED TO THE IMPLANT SHEET FROM THE (B)(6) 2018 PROCEDURE, INDICATE THAT A TIBIAL TRAY AND ONE STEM EXTENDER (IMPLANTED (B)(6) 2008) WITH A FEMORAL COMPONENT, INSERT, AUGMENT BLOCKS, AND ANOTHER STEM EXTENDER (IMPLANTED (B)(6) 2015) WERE REVISED TO A COMPLETE TS KNEE CONSTRUCT AS JUST DESCRIBED WITH THE ADDITION OF MORE AUGMENTATION BLOCKS AND AN OFFSET ADAPTER. REVISION WAS DUE TO INSTABILITY. THE REP HAS SAID THE BASEPLATE REMAINED IMPLANTED. THE 13X80 STEM REMAINS IMPLANTED. THE 21X80 STEM HAD TO COME AS IT IS ATTACHED TO THE FEMORAL COMPONENT, THERE WAS NO ALLEGATION AGAINST THE STEM OR THE AUGMENTS.

  Patient problems: Injury

  MAUDE report 7646539 ↗

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-0875-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
• 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-0881-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
• Z-0876-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
• 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