STEM PC XSHORT 2 17043Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M209170430), received between Jun 30, 2020 and Jun 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 30, 2020Fracture

  ON 6/25/2020 BIOPRO WAS NOTIFIED OF A FAILED EXTRA SHORT HIP STEM. THE STEM WAS IMPLANTED ON (B)(6) 2009. AN ADDITIONAL PHONE CALL WAS HELD WITH THE SURGEON ON 6/29/2020 TO GATHER MORE INFORMATION. THE PATIENT WAS EXPERIENCING PAIN FOR QUITE A WHILE, BUT WAS WALKING. WHEN SHE EXPLAINED THE PAIN AN X-RAY WAS PERFORMED AND THE FRACTURE OF THE HIP STEM WAS EVIDENT. SHE INDICATED THAT 2 YEARS PREVIOUSLY SHE HAD SUFFERED A FALL. UPON REVIEW OF AN X-RAY TAKEN IN 2019 A HAIR LINE FRACTURE IN THE HIP STEM WAS EVIDENT, BUT NOT NOTED AT THE TIME OF THE X-RAY. IT IS UNKNOWN WHEN THE HIP STEM FAILED, BUT REMODELING OF THE BONE AROUND THE DISTAL END OF THE IMPLANT IS INDICATIVE OF THE IMPLANT MOVING WITHIN THE BONE FOR AN EXTENDED PERIOD OF TIME. ADDITIONALLY, WHEN THIS HIP WAS IMPLANTED IN 2009 THE SURGEON UTILIZED A TECHNIQUE WHICH RESULTED IN THE HIP STEM REMAINING SOMEWHAT MORE PROXIMAL, THE SURGEON HAS SINCE MODIFIED HIS IMPLANT TECHNIQUE. THE HIP WILL BE REMOVED AND WILL BE EXAMINED WHEN IT IS RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 10214464 ↗