STEM PC XSHORT 3 17044Recalls & reported problems
Biopro, Inc. · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M209170440), received between Oct 26, 2015 and Oct 26, 2015 — classified as 1 malfunction.
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
Device problems
- Fracture1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2015Fracture
PATIENT WENT TO DOCTOR'S OFFICE WITH PAIN IN THE HIP. X-RAYS WERE DONE TO DIAGNOSE THE SOURCE OF THE PAIN AND IT WAS DISCOVERED THAT THE HIP STEM WAS BROKEN. THE DOCTOR INDICATED THAT THE PATIENT HAS GAINED A SIGNIFICANT AMOUNT OF WEIGHT SINCE THE HIP WAS IMPLANTED AND THAT HE SUFFERS FROM MULTIPLE MEDICAL ISSUES. THE DOCTOR WAS TOLD THAT SOMEONE HAD SAT ON THE PATIENT'S LEG IN AN ATTEMPT TO RESTRAIN HIM AT SOME POINT.
Patient problems: Failure of Implant
MAUDE report 5179056 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.