Hip Instruments 01.08.10.0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040738408), received between May 31, 2023 and May 31, 2023 — classified as 1 injury.

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

• InjuryMay 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER THE REPOSITIONING OF THE BIPOLAR HEAD, THE STRAIGHT IMPACTOR DETACHED FROM THE MULTIFUNCTION HANDLE AND REMAINED IN THE SOFT TISSUES OF THE FEMUR. DESPITE MULTIPLE INDICATIONS BY THE NURSE THAT THE IMPACTOR WAS MISSING, THE SURGEON CLOSED THE WOUND. AFTER SURGERY, A CT-SCAN WAS PERFORMED AND THE IMPACTOR WAS VISIBLE ON THE IMAGES, SO A REVISION SURGERY WAS PERFORMED ON THE (B)(6) TO REMOVE THE IMPACTOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17029862 ↗