ZUK 00584305400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556621677), received between Sep 13, 2018 and Sep 20, 2020 — classified as 3 malfunctions.

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

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.

• MalfunctionSep 20, 2020Break; Break

  IT WAS REPORTED THAT DURING UNICOMPARTMENTAL KNEE SURGERY, WHEN REMOVING THE ZUK UNI FEMORAL PROVISIONAL SIZE F RM/LL THE THREADS OF THE INSERTION HANDLE BROKE OFF OUTSIDE THE PATIENT, AND ARE STUCK INSIDE THE ZUK UNI FEMORAL PROVISIONAL SIZE F RM/LL. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY AND NO INJURY TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10558070 ↗
• MalfunctionMar 11, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT T-HANDLE THREADS WERE STRIPPED. NO DELAY TO PROCEDURE. SMITH AND NEPHEW DEVICE WAS NOT REQUIRED AS. UPDATE 2/28/2019: T-HANDLE BROKE DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409156 ↗
• MalfunctionSep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DEVICE WAS FOUND STRIPPED DURING SURGERY. SURGERY WAS COMPLETED WITHOUT THE USAGE OF THE DEVICE AND THERE WAS NO BACKUP AVAILABLE. HOWEVER, NO PATIENT INJURY WAS INVOLVED AND THERE WAS NO DELAY TO THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874407 ↗