NA 1294-35-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295026006), received between Dec 27, 2017 and Feb 18, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558747 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ANTIBIOTIC SPACER IMPLANTED. DOI: UNKNOWN; DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7446213 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT WAS REVISED FOR A PAINFUL KNEE. THE TIBIA WAS REMOVED AND REPLACED WITH A NEW ONE. DOI: UNKNOWN, DOR: (B)(6) 2017, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7147572 ↗