ZUK 00584102409Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556619513), received between Feb 26, 2020 and Apr 13, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION AFTER PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 4 9 MM WAS NOTICED CHIPPED. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655860 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT, UPON INSPECTION OF A TRAY, THE ARTICULAR SURFACE PROVISIONAL SIZE 4 9MM WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11052189 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT, UPON INSPECTION OF SET, IT WAS NOTICED THAT ARTICULAR SURFACE PROVISIONAL WAS BROKE IN HALF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972043 ↗
• InjuryOct 28, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHILE TRIALING A STANDARD UNICOMPARTMENTAL KNEE WHEN THE INSERT TRIAL SNAPPED IN HALF. ALL PIECES RETRIEVED WITH NO PATIENT ISSUES. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10747841 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TRIAL BROKE. IT BROKE INSIDE THE PATIENT AND ALL THE PIECES WERE RECOVERED. S+N BACKUP DEVICE WAS AVAILABLE AND USED. DELAY UNDER 30 MIN, NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753954 ↗