Scorpio 72-15-0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154020157), received between Sep 5, 2019 and Sep 5, 2019 — classified as 1 injury.

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

3 other recalls cover devices cleared under the same FDA submission (K041591, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2019Degraded; Naturally Worn; Degraded; Naturally Worn

  A SCORPIO TKR REQUIRED A CHANGE OF POLY LINER FOR POLY WEAR. THE ORIGINAL COMPONENT WAS IMPLANTED ON (B)(6) 2005. IN THE PROCESS OF CHANGING THE POLY LINER, THE SERIES 7000 CEMENTED BASEPLATE WAS ALSO FOUND TO BE LOOSE. IT CAME OUT WITH NO CEMENT ADHERING TO IT, ALTHOUGH THE CEMENT BONE INTERFACE WAS INTACT. THE SURGEON REQUESTED NO TIBIAS OR FEMURS BE SENT. AS THERE WAS NO REPLACEMENT TIBIA ON HAND, THE EXISTING TIBIA WAS RE-CEMENTED IN PLACE. A NEW 12MM PS POLY WAS IMPLANTED, AND THE PATELLA WAS RESURFACED USING A SZ 5 SCORPIO PATELLA. ONLY THE INSERT IS AVAILABLE FOR RETURN. THE TIBIA WAS RE IMPLANTED. THERE ARE NO OTHER NOTES ETC AVAILABLE. THE X-RAY WAS TAKEN ON (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8964497 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041591, K243817. 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-0883-2024 · Dec 1, 2023 · Open, Classified
  Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324