ZUK 00584102408Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885556619506), received between Mar 11, 2019 and Sep 2, 2021 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM BROKE. NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418215 ↗
• MalfunctionJul 5, 2021Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE FOLLOWING DEVICES WERE FOUND BROKEN: ONE (1) GENESIS II FEMORAL IMPLANT IMPACTOR ((B)(4)), ONE (1) OR3O DUAL MOBILITY TRIAL LINER 36/48 ((B)(4)), SIXTEEN (16) TRIGEN LIDS FOR OUTER CASES ((B)(4)), SEVEN (7) TRIGEN SMALL OUTER CASES - 2.4 ((B)(4)), THREE (3) TRIGEN LARGE OUTER CASES - 4.8, ((B)(4)), ONE (1) ZUK ARTICULAR SURFACE PROVISIONAL SIZE 4 8MM ((B)(4)), AND ONE (1) JOURNEY II BCS LOCKING FEMORAL IMPLANT IMPACTOR ((B)(4)). THIS WAS NOTED AS A DAMAGE DURING SHIPPING. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114785 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT, A ZUK INSERT TRIAL PLASTIC BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020558 ↗
• MalfunctionMay 31, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909284 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822524 ↗
• 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 11803010 ↗
• MalfunctionApr 22, 2021Break; Break

  IT WAS REPORTED THAT, THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM WAS FOUND IN 2 PIECES WHEN THE TRAYS WERE BEING PUT BACK TOGETHER IN THE STERILE PROCESSING DEPARTMENT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711048 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PAIR OF SZ 4 8MM ZUK INSERT SURFACE TRL HAD THE TABS BROKEN. INCIDENT WAS NOTICED DURING INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610658 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT A PAIR OF SZ 4 8MM ZUK INSERT SURFACE TRL HAD THE TABS BROKEN. INCIDENT WAS NOTICED DURING INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610639 ↗
• InjuryMar 4, 2021Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE POLY TRIAL CRACKED WHEN TRYING TO TAKE IT OUT OF THE PATIENT. THIS WAS A JOURNEY (FEMUR) / ZUK (TIBIA) UNICOMPARTMENTAL KNEE. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11417790 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL IN A ARTICULAR SURFACE PROVISIONAL SZ 4 8MM IS CHEWED UP AND NEEDS REPLACED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10871434 ↗
• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY OUTSIDE OF THE PATIENT THE DEVICE GOT BROKEN. THERE WAS NO DELAY NOR INJURY REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE TO FINISHED THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10539897 ↗
• InjuryAug 27, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT TRIALS BROKE WHILE THE INSTRUMENTS WERE INSIDE THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10462764 ↗
• InjuryAug 27, 2020Break; Break

  IT WAS REPORTED THAT THE INSERT TRIALS BROKE WHILE THE INSTRUMENTS WERE INSIDE THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10462759 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM CRACKED IN HALF DURING USE INSIDE THE PATIENT. NO DELAY. S&N BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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: No Information

  MAUDE report 10452260 ↗
• InjuryAug 24, 2020Crack; Crack

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM CRACKED ON THE CORNER. THIS HAPPENED DURING USE INSIDE THE PATIENT. NO DELAY. S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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: No Information

  MAUDE report 10446453 ↗
• MalfunctionAug 19, 2020Break; Break

  IT WAS REPORTED THAT DURING THE INSPECTION THE DEVICE WAS BROKEN. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 10426421 ↗
• MalfunctionJul 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE POLY PIECES WERE FOUND WORN, WITH BROKEN SIDES AND WILL NOT INSERT FULLY. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10279833 ↗
• MalfunctionJul 13, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ARTICULAR SURFACE PROVISIONAL SZ 4 8MM BROKE. IT BROKE OUTSIDE THE PATIENT. ALL PIECES WERE RECOVERED. NO PIECES FELL INSIDE THE PATIENT. NO DELAY. THE PROCEDURE WAS FINISHED WITH A S&N BACK UP DEVICE. 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 10268190 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED THAT THE TRIAL HAS DEVELOPED A HORIZONTAL CRACK. NO CASE INVOLVED. NO INJURY REPORTED. 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 10207130 ↗
• MalfunctionApr 22, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHILE PLACING THE TRIAL IN DURING CEMENTING, THE LEG WAS EXTENDED AND THE TRIAL SNAPPED IN TWO PIECES. NO INJURY NOR DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9988178 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE TRIAL SNAPPED IN HALF INSIDE THE PATIENT (ALL THE PIECES WERE RECOVERED). THERE WAS ANOTHER S&N BACKUP TRIAL AVAILABLE. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440685 ↗
• MalfunctionNov 29, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TRIAL SEATED CORRECTLY BUT SNAPPED WHEN THE KNEE WAS FLEXED. ALL THE PIECES WERE RECOVERED. THERE WAS A BACKUP DEVICE AVAILABLE. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392047 ↗
• MalfunctionOct 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TRIAL BROKE DURING REMOVAL AFTER TRIALING THE KNEE. LESS THAN 30 MINUTES DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. THE BREAKAGE OF THE DEVICE WAS NOT CORROBORATED AFTER THE DEVICE WAS EVALUATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258139 ↗
• 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 8660901 ↗