Hip Instruments 01.10.10.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040748414), received between Dec 18, 2025 and Dec 18, 2025 — 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.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PLANNED STEM WAS A SIZE 3 STANDARD QUADRA P CEMENTED. POSTERIOR APPROACH USED. ALTHOUGH THE FEMUR WAS PREPARED TO SIZE 3 AND TRIALED WITH A 36 S HEAD, THE HIP COULD NOT BE REDUCED. THIS WAS UNEXPECTED, AS THE PLANNED OFFSET AND LEG LENGTH CHANGES WERE MINIMAL, AND INTRAOPERATIVE CHECKS SUGGESTED THE STEM WAS POSITIONED AS INTENDED. DOWNSIZING TO A SIZE 2 STILL DID NOT ALLOW REDUCTION. AS SHORT-NECK STEMS WERE NOT AVAILABLE, A SIZE 1 BROACH WAS USED AND SEATED APPROXIMATELY 5 MM DEEPER. AN ATTEMPT TO REDUCE THE HIP WITHOUT CALCAR REAMING RESULTED IN A MEDIAL CALCAR FRACTURE, WHICH WAS MANAGED WITH A CABLE. A SIZE 1 STANDARD QUADRA P CEMENTED STEM WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES. POST-OPERATIVE X-RAY SHOWS A SLIGHT INCREASE IN OFFSET AND A SLIGHT DECREASE IN LEG LENGTH.

  Patient problems: Bone Fracture(s)

  MAUDE report 23838612 ↗