INSTRUMENT 8000-0000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327234206), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionSep 6, 2018Fracture; Fracture

  THIS PI IS FOR THE INTRA-OPERATIVE EVENT ON (B)(6) /2018. IN PERFORMING A REVISION OF THE PATIENT'S RIGHT HIP, THE DISTAL CONE BODY WAS FOUND TO BE COLD WELDED TO THE DISTAL STEM. IN USING THE STEM SEPARATOR AND THE HANDLE WHICH ATTACHES TO IT, A PART OF THE STEM SEPARATOR BROKE, AND THE TIP OF THE HANDLE SNAPPED OFF. SURGEON HAD TO INSTEAD PERFORM AN EXTENSIVE TROCH OSTEOTOMY PROCEDURE, LEADING TO A SURGICAL DELAY OF APPROXIMATELY 5 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852231 ↗