Hip Instruments 01.10.10.190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040746809), received between Feb 15, 2019 and Oct 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionOct 11, 2024Material Integrity Problem; Material Integrity Problem

  DURING HIP PRIMARY SURGERY, THE SURGEON WANTED TO REMOVE THE STD SIZE 4 STEM AS IT WAS IMPLANTED A WRONG SIZE RESULTING IN A TOO HIGH IMPLANT AND IMPLANT A SIZE 3. HOWEVER, THE FIXATION WAS GOOD AND THE SURGEON COULD NOT GET THE STEM OUT, USING THE STEM REPOSITIONER AND SCREWED STEM EXTRACTOR. AFTER REPEATED ATTEMPTS, THE STEM REPOSITIONER HAD WORN OUT AND THE STEM WAS LEFT IN PLACE. THE DEVICE WAS NOT DAMAGED BEFORE USING IT. CUP SIZE S AND STD SIZE 4 STEM HAS BEEN IMPLANTED, WITH THE PLANNED OFFSET. ONE HOUR DELAY OCCURRED TO RELEASE ALL LIGAMENTS TO INCREASE THE LEG'S LEGHT (TOTAL TIME SUGERY 2HR AND 15MIN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426603 ↗
• MalfunctionFeb 15, 2019Break

  DURING THE PRIMARY HIP SURGERY AND AFTER ALL COMPONENTS WERE IMPLANTED, THE SURGEON WAS NOT ABLE TO REDUCE THE PATIENT. THE SURGEON ATTEMPTED TO EXTRACT THE STEM WITH THE STEM REPOSITIONER BUT THE STEM WAS WELL FIXED AND HE WAS NOT ABLE TO EXPLANT THE STEM. DURING THE PROCESS OF ATTEMPTING TO EXTRACT THE STEM, THE STEM REPOSITIONER WAS STRUCK WITH A MALLET AND IT BROKE. AFTER FURTHER EXAMINATION, THE SURGEON DETERMINED THAT THE REASON HE WAS NOT ABLE TO REDUCE THE PATIENT WAS THAT THE STEM WAS CONTACTING THE ACETABULUM. THE SURGEON THEN REMOVED A SMALL PORTION OF BONE FROM THE ACETABULUM AND THE PATIENT WAS EASILY REDUCED. THERE WAS A 40-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS FELL INTO THE PATIENT. ADDITIONAL INFORMATION: THE INSTRUMENT BROKE AFTER BEING STRUCK WITH MALLET: THE CIRCLED AREA IS THE BROKEN PART OF THE INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8343137 ↗