ZUK 00584102208Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556619384), received between Mar 7, 2019 and Oct 4, 2021 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• InjuryOct 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNICOMPARTMENTAL KNEE SURGERY, AN ARTICULAR SURFACE PROVISIONAL SZ 2 8MM BROKE OFF. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569087 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE THE INSTRUMENT WAS INSIDE THE PATIENT, THE ARTICULAR SURFACE PROVISIONAL SZ 2 8MM BROKE. ALL THE BROKEN PIECES WERE RETRIEVED WITH A HEMOSTAT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849833 ↗
• 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 11566419 ↗
• MalfunctionNov 20, 2020Pitted; Pitted

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 2 8MM PRESENTS GOUGES AND PIECES COMING OFF OF THEM. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10878114 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC ON THE ARTICULAR SURFACE PROVISIONAL WAS NOTICED TO BE CHIPPED DURING CLEANING/STERILIZATION. NO SURGERY OR PATIENT WAS 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 10847789 ↗
• InjuryJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE POLY LOCKING TAB BROKE, THIS OCCUR INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262252 ↗
• MalfunctionAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE ZUK INSERT TRIAL BROKE. NOTHING GOT IN PATIENT. NO HARM TO PATIENT OR STAFF. NO LETTER REQUIRED AT THIS TIME. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. THE DEVICE BROKE OVER THE PATIENT'S INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892465 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SZ 2, 8MM TRIAL CRACKED UPON INSERTION. THE TRIAL WAS SLIGHTLY CRACKED SO WAS STILL ABLE TO USE IT, AND A BACK-UP DEVICE WAS NO NEEDED. THE PROCEDURE WAS COMPLETED SATISFACTORY WITHOUT DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8401548 ↗