Scorpio 70-3011RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327027983), received between Nov 18, 2020 and Nov 18, 2020 — classified as 1 injury.

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

7 other recalls cover devices cleared under the same FDA submission (K974556); 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.

• InjuryNov 18, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN (B)(6) 2014 WITHOUT COMPLICATIONS. ON (B)(6) 2020, THE PATIENT RETURNED TO THE OFFICE WITH PAIN AND LIMITED MOVEMENT, RADIOLOGICAL CONTROL WAS PERFORMED AND THE FEMORAL COMPONENT BROKE AND LOOSENED. THE DOCTOR THEREFORE NOTED THE NEED TO PERFORM A PROSTHESIS REVIEW. NOTE: THE REVIEW PROCEDURE WAS CARRIED OUT WITH MATERIAL FROM ANOTHER BRAND / DISTRIBUTOR.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10859094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974556. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-0468-2010 · Oct 2, 2009 · Terminated
  Scorpio PS Basic Femur; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplast
• Z-0466-2010 · Oct 2, 2009 · Terminated
  Scorpio CR Basic Femur with Posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee
• Z-0467-2010 · Oct 2, 2009 · Terminated
  Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total
• Z-0059-06 · Aug 11, 2005 · Terminated
  Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
• Z-0058-06 · Aug 11, 2005 · Terminated
  Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
• Z-1381-2008 · Feb 8, 2005 · Terminated
  Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stry