ZUK 00584102509Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556619575), received between Mar 11, 2019 and Apr 22, 2021 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNICONDYLAR KNEE REPLACEMENT, THE ARTICULAR SURFACE PROVISIONAL SZ 5 9MM SPLIT IN HALF WHEN PERFORMING A TRIAL. THE DEVICE BROKE INSIDE THE PATIENT AND ALL THE PIECES WERE REMOVED BY HAND. A DELAY LESS OR EQUAL THAN 30 MINUTES WAS REPORTED AND THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11711107 ↗
• InjuryFeb 22, 2021Break; Break

  IT WAS REPORTED THAT DURING USE, INSIDE THE PATIENT, THE TRIAL POLY SNAPPED IN HALF WHILE ATTEMPTING TO TRIAL. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357009 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE BROKEN DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072085 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 5 9MM IS BROKEN. THERE WAS NO CASE INVOLVED. 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 11015958 ↗
• MalfunctionOct 6, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS RETURNED BROKEN IN HALF. NO PATIENT INVOLVED IN THE CASE. 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; No Patient Involvement

  MAUDE report 10638063 ↗
• InjuryAug 11, 2020Crack; Crack

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 5 9MM BROKE UPON TRIALING AND IMPACTION, IT CRACKED RIGHT IN THE MIDDLE. THE DEVICE BROKE INSIDE THE PATIENT AND ALL PIECES WERE RECOVERED. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. NO HARM TO PATIENT OR DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393941 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIBIAL INSERT TRIAL BROKE. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE WITH NO DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512747 ↗
• MalfunctionMar 11, 2019Break; Break

  IT WAS REPORTED THAT WHILE TRIALING THE ITEM BROKE. NO INJURIES O OR DELAYS REPORTED. BACK-UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408827 ↗