ZUK 00133602800Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556618738), received between Jun 18, 2020 and Oct 6, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 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.

• MalfunctionOct 6, 2021Break; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A FEMORAL IMPACTOR WAS SCARRED/DAMAGED. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. INVESTIGATION SHOWS THAT THE FEMORAL IMPACTOR WHITE HEAD IS MISSING FROM THE DEVICE DUE TO FRACTURE. 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 12584597 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, THE FEMORAL IMPACTOR TIP BROKE OFF IN HANDLE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE OF THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED AND IF IT WAS DELAYED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277285 ↗
• MalfunctionJun 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING FILED INSPECTION, THE FEMORAL IMPACTOR WAS FOUND TO BE BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934873 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT AFTER A TKA SURGERY, THE FEMORAL IMPACTOR TIP IS MUSHROOMED AND CHIPPED THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704454 ↗
• MalfunctionApr 21, 2021Break; Break

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION THE ZUK FEMORAL IMPACTOR HAS THE TIP BROKEN OFF INSIDE. NO CASE INVOLVED, THEREFORE NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704450 ↗
• MalfunctionMar 13, 2021Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR WAS NOTICED BROKEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478630 ↗
• InjuryJan 6, 2021Break; Break

  IT WAS REPORTED THAT, IN A UKR PROCEDURE, THE PLASTIC TIP OF THE FEMORAL IMPACTOR BROKE OFF DURING IMPACTION. THERE WAS NO DELAY, AND PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124617 ↗
• InjuryDec 30, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE TIP OF THE FEMORAL IMPACTOR BROKE OFF DURING IMPACTION (INSIDE THE PATIENT). ALL PIECES HAVE BEEN RECOVERED. NO HARM TO PATIENT OR STAFF. THERE AS NO DELAY. PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. NO OTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094898 ↗
• MalfunctionNov 22, 2020Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE, THE FEMORAL IMPACTOR (ZUK) WAS FOUND CHIPPED. ITEM WAS USED T COMPLETE THE PROCEDURE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10882117 ↗
• MalfunctionJun 25, 2020Break; Break

  IT WAS REPORTED THAT UPON OPENING SET REP NOTICE THAT THE PLASTIC IMPACTOR TIP WAS BROKE, THERE WAS NO DELAY NOR INJURY INVOLVED. A S&N BACKUP DEVICE WAS AVAILABLE TO FINISH THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10194066 ↗
• MalfunctionJun 18, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP OF IMPACTOR BROKE. THIS WAS NOTICED DURING INSPECTION FOR A TKA PROCEDURE. NO DELAY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10171282 ↗