InSitu Hip System 10-10-0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816127021978), received between Sep 11, 2019 and Sep 20, 2019 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT LOST BALANCE AND SAT DOWN HARD IN HER WHEELCHAIR WHILE STANDING UP, CAUSING A FEMUR FRACTURE. X-RAYS WERE TAKEN 6 DAYS POST-OPERATIVELY.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 9100648 ↗
• MalfunctionSep 11, 2019Appropriate Device Problem Term/Code Not Available

  A REVISION SURGERY WAS CONDUCTED AND THE STEM AND HEAD WERE EXPLANTED AND A COMPETITOR'S STEM WAS IMPLANTED. THE PATIENT CLAIMS THERE WERE NO POST-OP EVENTS OR FALLS, AND THE POST-OP X-RAY LOOKED SATISFACTORY ACCORDING TO THE SURGEON. THE SURGEON BELIEVES THERE WAS A POSSIBLE UNIDENTIFIED INTER-OPERATIVE FRACTURE.

  Patient problems: No Code Available

  MAUDE report 8995821 ↗