Scorpio 72-25-1110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327029802), received between Jun 6, 2018 and Feb 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K051977); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE (B)(6) 2020 REVISION. PATIENT UNDERWENT PRIMARY TKA OUTSIDE OF CORS SCOPE. HAD A REVISION TKA FOR PJI ON (B)(6) 2018. WITH EXCHANGE OF POLYETHYLENE ONLY. THE PATIENT HAD RECURRENCE OF INFECTION AND HAD A REVISION TKA ON (B)(6) 2020. WHERE ALL COMPONENTS WERE EXCHANGE (PRE-CORS SCOPE AND POLY).

  Patient problems: Unspecified Infection

  MAUDE report 11366299 ↗
• InjuryOct 22, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT EXAMINATION SHOWED THE FEMUR SUBLUXING ANTERIORLY AROUND 100 DEGREES OF FLEXION AND THEN REDUCING BACK INTO POSITION AROUND 45 DEGREES OF FLEXION.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9221087 ↗
• InjuryJun 6, 2018Fracture; Fracture

  THE HOSPITAL WISHED TO REPORT THE OCCURRENCE BROKEN POLY. IT WAS REPORTED THAT THE PRIMARY SURGERY WAS CONDUCTED IN 2009.

  Patient problems: Injury

  MAUDE report 7574229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051977. One submission often covers many models, so check the product and lot details in each record.

• Z-0911-2010 · Feb 17, 2006 · Terminated
  Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless compo