ZUK 00584102508Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00885556619568), received between Aug 10, 2018 and Jul 21, 2021 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT AN ARTICULAR SURFACE PROVISIONAL SZ 5 8MM WAS FOUND CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201309 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY WHILE THE INSTRUMENTS WAS OUTSIDE OF THE PATIENT, THE ARTICULAR SURFACE PROVISIONAL SZ 5 8MM WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046451 ↗
• MalfunctionJun 12, 2021Break; Break

  IT WAS REPORTED THAT, THE ARTICULAR SURFACE PROVISIONAL SZ 5 8MM BROKE IN HALF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988798 ↗
• MalfunctionMay 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, AN ARTICULAR SURFACE PROVISIONAL SZ 5 8 MM DEVICE WAS FOUND BROKEN IN HALF. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794660 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 5 8 MM WAS NOTICED BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770716 ↗
• InjuryApr 23, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BOTTOM OF AN ARTICULAR SURFACE PROVISIONAL SZ 8MM WAS CHIPPED DURING TRIALING, ALL PIECES WERE RETRIEVED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720898 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT, THE ARTICULAR SURFACE PROVISIONAL SZ 5 8MM BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693225 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING EFIP INSPECTION, IT WAS NOTICED THAT THE TIBIA SPACER WAS CHIPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671415 ↗
• MalfunctionFeb 15, 2021Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING INSPECTION THE SZ 5 8MM ZUK NSERT TRL PRESENTED STRONG WEAR/DAMAGE ON THE EXTRUDED TRIAL. NO CASE REPORTED THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, DURING THE INSPECTION OF THE DEVICE IT WAS CONFIRMED THAT THE DEVICE IS HEAVILY GOUGED. 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 11326574 ↗
• MalfunctionFeb 14, 2021Break; Break

  IT WAS REPORTED THAT, AN ARTICULAR SURFACE PROVISIONAL SZ 5 8MM IS CHIPPED. INCIDENT OCCURRED DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326215 ↗
• InjuryFeb 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY THE ZUK SZ. 5 8MM ZUK POLY TRIAL WAS PLACED IN THE PATIENT FOR SIZING AND BROKE IN HALF INSIDE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325744 ↗
• InjuryFeb 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A UKR PROCEDURE, ARTICULAR SURFACE PROVISIONAL SZ 5 8MM DEVICE BROKE IN HALF LENGTH WISE WHEN THE SURGEON WAS INSERTING. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. THERE WERE 2 PIECES, NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283557 ↗
• 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 11174730 ↗
• MalfunctionDec 30, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING SURGERY, ARTICULAR SURFACE PROVISIONAL SZ 5 8MM CRACKED IN HALF WHILE INSIDE THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097941 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT WHILE SETTING UP FOR THE SURGERY THE ZUK SZ 5 8MM TRIAL WAS NOTICED TO BE BROKEN. A BACK UP S&N ITEM WAS AVAILABLE, THERE WAS NO DELAY, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089262 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TRIAL 8MM INSERT BROKE DURING CEMENTING FOR A UNI KNEE, JZ CONSTRUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH+NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR 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 10980094 ↗
• InjuryNov 11, 2020Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL BROKE WHILE TRIALING. THE INCIDENT OCCURRED DURING USE, WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. 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 10824994 ↗
• MalfunctionNov 11, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT TRIAL WAS NOTICED TO BE 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 10823554 ↗
• InjuryOct 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A ZUK CASE, THE ARTICULAR SURFACE PROVISIONAL SZ 5 8MM WAS BREAKING . IT OCCURRED AFTER THE FEMORAL AND TIBIAL IMPLANTS WERE CEMENTED IN. THE SURGEON TRIED TO TRAIL WITH THE 9MM AND DETERMINED THAT IT WAS A TOUCH TO BIG. THE PROCEDURE WAS COMPLETED BY TRIALING THE ACTUAL 8MM POLY. NO DELAY IN THE CASE. NO PIECES FELL INTO THE PATIENT. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10698242 ↗
• MalfunctionFeb 3, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, GAP SPACE BETWEEN THE FEMORAL AND TIBIAL COMPONENT WAS TOO TIGHT. SURGEON TRIED TO FORCE THE TIBIAL INSERT TRIAL INTO SPACE, CAUSING IT TO BREAK. NO DELAY. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9658951 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL CRACKED DOWN THE MIDDLE. NO INJURIES OR DELAYS REPORTED. BACKUP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104535 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT TRIALS BROKE UPON TRIALING. NO INJURY REPORTED. IS UNKNOWN IF A DELAY OCCURRED OR IF A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660902 ↗
• MalfunctionApr 15, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE CRACKED DURING A CASE. THE PROCEDURE WAS COMPLETED WITH NO DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512714 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING CASE. NO DELAY, INJURY OR AN AVAILABLE BACK UP DEVICE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475274 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, TIBIAL TRIAL BROKE WHILE TRIALING COMPONENTS . NO DELAY. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED. ALL PIECES WERE RECALLED AND REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452411 ↗