INSTRUMENT 7004-0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327364514), received between Dec 26, 2019 and Dec 26, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2019Device Difficult to Setup or Prepare; Difficult or Delayed Separation; Device Difficult to Setup or Prepare; Difficult or Delayed Separation

  SURGEON IMPLANTED A TRIDENT II TRITANIUM, 52MM CLUSTERHOLE CUP INTO A PATIENT. WHEN HE PROCEEDED TO UNSCREW THE TRIDENT II IMPACTOR, HE WAS UNABLE TO TURN THE WHEEL AND RELEASE THE IMPACTOR FROM THE CUP. HE HAD TO EXPLANT THE CUP AND REAM UP TO A 54 TRIDENT II CLUSTERHOLE CUP AND RE-IMPLANT ITH AN ORIGINAL TRIDENT IMPACTOR. HE COULD NOT DISENGAGE THE IMPACTOR FROM THE CUP. UPDATE: IF A MAGNETIC BOLT WAS INVOLVED,... NO SURGICAL DELAY OF APPROX 7-8 MINS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9520427 ↗