InSitu Hip System 10-10-0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816127021992), received between May 31, 2018 and Jan 9, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ALSO DESCRIBED IN 3002498892-2025-00032 AND 3002498892-2025-00033. IT WAS REPORTED THAT THE FEMORAL STEM SUBSIDED. THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED.

  Patient problems: Unequal Limb Length

  MAUDE report 24028720 ↗
• MalfunctionJul 15, 2021Fracture; Material Deformation

  TWO-WEEKS POST-OP THE PATIENT HEARD A POP WHILE GETTING OFF THE TOILET. XRAY SHOWED A PERIPROSTHETIC FEMUR FRACTURE AND SIGNIFICANT STEM SUBSIDENCE. SURGEON REVISED THE STEM ONLY WITH A COMPETITOR STEM.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 12175853 ↗
• MalfunctionSep 6, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL POST-OP AND FRACTURED HER FEMUR. A REVISION SURGERY WAS CONDUCTED AND THE STEM AND HEAD WERE EXPLANTED AND A COMPETITOR'S STEM WAS IMPLANTED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 8972207 ↗
• InjuryMay 31, 2018Fracture; Inadequacy of Device Shape and/or Size

  PATIENT HEARD A POP AND FEW DAYS LATER REPORTED TO CLINIC WITH DISCOMFORT. SURGEON DETERMINED THAT THERE WAS A FRACTURE. THE FEMORAL HEAD AND STEM WERE REMOVED. AFTER GOING TO REHAB FACILITY PATIENT FELL AND WAS FOUND ON FLOOR BY STAFF. A LONGER STEM AND NEW FEMORAL HEAD WERE THEN IMPLANTED ALONG WITH CABLES THIS TIME.

  Patient problems: Discomfort; Fall

  MAUDE report 7558513 ↗
• InjuryMay 31, 2018Fracture

  SURGEON HAD A FRACTURED FEMUR COME TO HIS ATTENTION POST-OP. HE CHOOSE TO THEN REVIS THE PATIENT. REMOVED FEMORAL STEM AND HEAD. CUP AND LINERS WERE NOT REMOVED.

  Patient problems: No Code Available

  MAUDE report 7558492 ↗