ZUK 00584102608Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556619629), received between Jan 21, 2019 and May 18, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN SURGEON WAS TRYING THE ARTICULAR SURFACE PROVISIONAL SZ 6 8MM THIS BROKE IN HALF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845670 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A CASE, THE TRIAL BROKE WHILE REMOVING FROM TIBIA TRIAL. THE DEVICE BROKE WHILE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685225 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL TRIALS ARE CHIPPED AND BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566426 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING UNI SURGERY THE ARTICULAR SURFACE PROVISIONAL SZ 6 8MM BROKE IN HALF OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376968 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT, THE TRIAL OF AN ARTICULAR SURFACE PROVISIONAL SZ 6 8MM IS BROKEN AND WILL NOT SEAT INTO TIBIA TRIAL. INCIDENT OCCURRED DURING A UKA WITH INSTRUMENTS OUTSIDE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123190 ↗
• MalfunctionNov 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 6 8MM IS CHEWED UP. 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 Patient Involvement

  MAUDE report 10823526 ↗
• MalfunctionAug 18, 2020Crack; Crack

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 6 8MM IS PRESENTING A LONG CRACK RUNNING THROUGH THE MIDDLE, NOT USABLE FOR SURGERY. NO DELAY OR BACK UP APPLICABLE FOR THIS CASE. NOTICED DURING WAREHOUSE INSPECTION.

  Patient problems: No Patient Involvement

  MAUDE report 10423238 ↗
• MalfunctionJun 23, 2020Crack; Crack

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION THE TRIAL CRACKED IN HALF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH &NEPHEW BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183229 ↗
• MalfunctionJul 28, 2019Break; Break

  IT WAS REPORTED THAT THE PLASTIC TRIAL BROKE DURING TRIAL RANGE OF MOTION. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE WAS NOT AVAILABLE. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834707 ↗
• MalfunctionMar 12, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIBIAL TRIAL BROKE IN HALF. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414254 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY IT WAS TRIED TO PUT IN TRIAL POLY BUT IT BROKE IN HALF. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265738 ↗