Scorpio 82-2-0910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540400741), received between May 20, 2019 and Jan 23, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K042343, 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.

Recalls naming this device

1. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0900-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT TOTAL KNEE WASH OUT / POLY SWAP DUE TO INFECTION TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 24159506 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "JOINT LAXITY, RIGHT TOTAL KNEE. DID POLY SWAP."

  Patient problems: Injury

  MAUDE report 9476424 ↗
• InjuryMay 20, 2019Unstable; Unstable

  PATIENT WITH A SCORPIO TKA IMPLANTED ON (B)(6) 2005 FELL AND SUBSEQUENTLY SOUGHT MEDICAL TREATMENT. DR. OBSERVED THE LEFT KNEE TO BE UNSTABLE DURING CLINICAL ASSESSMENT. PATIENT¿S LEFT KNEE WAS REVISED AND THE SIZE 9 10MM INSERT WAS REPLACED WITH A 15MM INSERT. THE KNEE WAS STABLE AND NO FURTHER PINTER ENTICING WAS DEEMED NECESSARY. THE EXPLANTED INSERT SHOWED SIGNS OF WEAR IN THE POSTERIOR MEDIAL ASPECT AND THE SUDDEN INSTABILITY WAS ATTRIBUTED TO A RUPTURED PCL DUE TO THE FALL.

  Patient problems: Fall; Injury; Rupture

  MAUDE report 8623506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042343, 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-1634-2015 · Aug 15, 2014 · Terminated
  Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of