ZUK 00584102308Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00885556619445), received between Feb 12, 2019 and Jan 4, 2022 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, AN ARTICULAR SURFACE PROVISIONAL SIZE 3 8MM BROKE DURING TRIALING. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THE ISSUE. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153207 ↗
• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A ARTICULAR SURFACE PROVISIONAL SIZE 3 8MM BROKE DURING TRIALING. IT IS UNKNOWN IF ANY DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE. SURGERY WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114998 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT AN ARTICULAR SURFACE PROVISIONAL SZ 3 8MM TRIAL IS BROKEN IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599280 ↗
• InjuryMay 13, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING UKR; WHEN PERFORMING A TRIAL REDUCTION, THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM SPLIT INTO TWO PIECES LONGITUDINALLY. BOTH PIECES WERE REMOVED AND NOTHING WAS LEFT BEHIND IN THE WOUND. THE PROCEDURE WAS FINISHED BY CHANGING THE SURGICAL TECHNIQUE. NO INJURY OR DELAY 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 11816249 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA, AN ARTICULAR SURFACE PROVISIONAL SZ 3 8MM, AN ARTICULAR SURFACE PROVISIONAL SZ 4 8MM AND A TENSION GAUGE, ALL THIS THREE ITEMS BROKE DURING SURGERY. INSTRUMENT OUTSIDE THE PATIENT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF THERE WAS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803028 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT TWO ARTICULAR SURFACE PROVISIONAL SZ 3 8MM WERE BROKEN. INCIDENT OCCURRED DURING SET UP OR INSPECTION; 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 11610601 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT TWO ARTICULAR SURFACE PROVISIONAL SZ 3 8MM WERE BROKEN. INCIDENT OCCURRED DURING SET UP OR INSPECTION; 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 11610595 ↗
• 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 11566379 ↗
• MalfunctionJan 27, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM IS WORN AND CHIPPED. IT IS UNKNOWN WHEN THIS MALFUNCTION OCCURRED AND IF THERE WAS A DELAY OR A BACK UP AVAILABLE. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240097 ↗
• InjuryJan 17, 2021Crack; Crack

  IT WAS REPORTED THAT DURING USE INSIDE THE PATIENT, THE ARTICULAR SURFACE TRIAL CRACKED DURING CEMENTING OF ZUK. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11183301 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION IT WAS FOUND THAT THE ZUK INSERT TRIAL WAS DAMAGED/BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174625 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE ARTICULAR SURFACE PROVISIONAL SIZE 3 8 MM CRACKED IN HALF. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979880 ↗
• MalfunctionNov 20, 2020Pitted; Pitted

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM PRESENTS GOUGES AND PIECES COMING OFF OF THEM. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10878119 ↗
• InjuryOct 22, 2020Crack; Crack

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM CRACKED IN HALF WHILE BEING USED TO TRIAL THE IMPLANTS INSIDE THE PATIENT. ALL PIECES RECOVERED. THERE WAS A S&N BACK UP DEVICE. NO DELAY. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10721858 ↗
• InjuryOct 16, 2020Break; Break

  IT WAS REPORTED THAT DURING UKR (NAVIO) PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM CRACKED WHILE TRIALING. THIS HAPPENED DURING USE INSIDE THE PATIENT. THERE WAS NO DELAY AND PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10693371 ↗
• InjuryAug 20, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE, WHEN THE SURGEON INSERTED THE ZUK SIZE 3X8MM INSERT TRIAL, IT CRACKED INTERNAL TO PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10433527 ↗
• MalfunctionAug 14, 2020Crack; Crack

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM WAS FOUND CRACKED DURING INSPECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10407955 ↗
• MalfunctionAug 12, 2020Crack; Crack

  IT WAS REPORTED THAT UPON INSPECTION IT WAS NOTICED THAT ARTICULAR SURFACE PROVISIONAL SZ 3 8MM WAS CRACKED. 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 10398699 ↗
• MalfunctionJun 9, 2020Crack; Crack

  IT WAS REPORTED DURING TKA PROCEDURE DURING SET UP THE DEVICE WAS FOUND CRACKED. NO HARM TO ANY PATIENT OCCURRED. NO DELAY. THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10133982 ↗
• MalfunctionMay 5, 2020Crack; Crack

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 3 8MM WAS FOUND TO BE CRACKED. AS THIS WAS NOTICED UPON INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10027220 ↗
• MalfunctionOct 11, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TRIAL BROKE IN HALF, THE ITEM BROKE INSIDE THE PATIENT BUT ALL PIECES WERE RECOVERED. S&N BACK-UP DEVICE AVAILABLE AND USED, DELAY UNDER 30 MIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182796 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT THE ART SURFACE BROKE DURING CEMENTING. BACKUP DEVICE AVAILABLE. NO INJURIES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727642 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT TRIAL LIP SNAPPED OFF. NO DELAY OR INJURY REPORTED. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8720143 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE CRACKED WHILE RANGING KNEE WITH CEMENTED COMPONENTS IN. NO HARM TO THE PATIENT OR STAFF. NOTHING LEFT INSIDE THE PATIENT. NO PROCEDURAL DELAYS. SMITH & NEPHEW BACK UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512719 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ITEM BROKE IN HALF. NO INJURIES OR DELAYS REPORTED. NO MORE INFORMATION PRESENTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493599 ↗