NA 00-5850-012-96 (UDI 00889024195639)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024195639), received between Jan 22, 2020 and Aug 23, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2021Off-Label Use; Off-Label Use

  THE PLASTIC SHEAF (POLY BOX) AT THE END OF THE ZSS DISTAL FEMUR WAS NOT PLACED ON THE FEMUR RESULTING ON THE PATIENT BEING RETURNED TO THE OR TWO DAYS LATER TO HAVE IT IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12355783 ↗
• InjuryMay 10, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 11797032 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 9769563 ↗
• InjuryJan 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST IMPLANTATION, THE PATIENT EXPERIENCED A FALL AND SUFFERED PAIN AND INSTABILITY. UPON X-RAY IMAGING, IT WAS IDENTIFIED THAT THE YOKE HAD FRACTURED. SUBSEQUENTLY, THE PATIENT WAS REVISED AND ALL FRACTURED COMPONENTS WERE EXCHANGED. DURING THE REVISION, THERE WAS FLUID NOTED IN THE KNEE JOINT AND DAMAGE NOTED TO THE POLY BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 9616029 ↗