ZUK 00584102309Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556619452), received between Mar 11, 2019 and Apr 12, 2021 — classified as 2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE ARTICULAR SURFACE PROVISIONAL SZ 3 9MM WAS FOUND TO BE DAMAGED. IT IS UNKNOWN WHAT TYPE OF DAMAGE IT WAS. THERE WAS NO CASE INVOLVED. THE INVESTIGATION FOUND THAT THE DEVICE IS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653877 ↗
• InjuryNov 16, 2020Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, ARTICULAR SURFACE PROVISIONAL SIZE 3 9MM WAS NOTICED TO BE BROKE IN HALF AND LAYING AT THE BOTTOM OF THE TRAY. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10844160 ↗
• MalfunctionOct 6, 2020Break; Break

  IT WAS REPORTED DURING INSPECTION AT LOANERS DEP THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 9MM WAS FOUND TO BE BROKEN IN HALF. NO APPARENT CASE INVOLVED OR INJURIES AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10638141 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT DURING THE INSPECTION PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 3.9MM WAS FOUND THAT THE TRIAL WAS CRACKED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10396094 ↗
• InjuryAug 11, 2020Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 9MM BROKE UPON TRIALING AND IMPACTION. IT BROKE CLEAN IN HALF. ALL PARTS WERE RECOVERED, BACK UP SET WAS AVAILABLE. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. 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 10394158 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT THE PROVISIONAL TRIAL BROKE DURING USE. NO PIECES FELL INSIDE THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247972 ↗
• MalfunctionMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE POLY INSERT TRIAL SNAPPED WHEN REMOVED AFTER TRAILING. NO DELAY AND NO BACK-UP DEVICE WAS AVAILABLE. NO INJURY INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8410173 ↗