CUPTIMIZE Advanced 4515-80-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295552093), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE SAME GLITCH OCCURRED WITH THE INCLINATION JUMPING UP 4-5MM AFTER ACCEPTING A NEW IMAGE. IT WAS RECOGNIZED IMMEDIATELY. THE SURGEON GOT THE FINAL CUP POSITION THAT HE WANTED 37/17. HE SEATED IT. HE TOOK ONE MORE SHOT AFTER SEATING THE CUP COMPLETELY. THE IMAGE WAS ACCEPTED AND MOVED TO THE ANALYSIS SCREEN. THE ELLIPSE SIZE DID NOT CHANGE BUT OBSERVED THE INCLINATION JUMP FROM 7 TO 42. ALSO WHEN I TRIED TO CHANGE THE CONTRAST ON BOTH THE AP PELVIS AND AP HIP X-RAYS THEY BOTH QUICKLY WENT DARK AND WAS UNABLE TO ADJUST. HAD TO X OUT OF THAT SCREEN AND START OVER WITH NEW X-RAY THEN JUST ACCEPT IT AS IT SHOWED UP. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750703 ↗