InSitu Hip System 10-21-3601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816127022494), received between Dec 22, 2017 and Jan 21, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ALSO DESCRIBED IN 3002498892-2025-00034 AND 3002498892-2025-00036. IT WAS REPORTED THAT THE FEMORAL STEM LOOSENED/SUBSIDED. THE FEMORAL STEM, FEMORAL HEAD, AND ACETABULAR LINER WERE REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 24134827 ↗
• InjuryJun 18, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE DISTRIBUTOR REPORTED THAT THE PATIENT WAS A HIGH BMI PATIENT THAT HAD LAXITY OVER TIME REQUIRING ADDED LENGTH ON THE HEAD. THERE WERE NO OTHER. COMPLICATIONS THAT HAPPENED WITH THE IMPLANTS. THE ORIGINAL SURGERY TOOK PLACE IN (B)(6) 2023. THE REVISION OF THE CERAMIC HEAD OCCURRED ON (B)(6) 2025.

  Patient problems: Joint Laxity

  MAUDE report 22287131 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem

  PATIENT HIP SYSTEM WAS REVISED DUE TO INFECTION. COMPLETE WASHOUT, COMPLETE EXPLANTATION AND REIMPLANTATION OF NEW COMPONENTS ALONG WITH ANTIBIOTIC POWDER.

  Patient problems: Unspecified Infection

  MAUDE report 7143696 ↗