inforMED
MalfunctionLPH

BIOPRO PSL HIP STEM

Received Oct 26, 2015 · Event occurred Oct 20, 2015

Report 1832656-2015-00001 · MDR key 5179056

Device

Generic name

Femoral Hip Stem

Manufacturer

Biopro Inc

Model number

17044

Catalog number

17044

Lot number

109675

Product problems

  • Fracture

Patient

65 YR

  • Failure of Implant

Narrative

Additional Manufacturer Narrative

WAITING FOR PHYSICIAN'S DETERMINATION IF THE DEVICE WILL BE REMOVED, SO THE EXPLANTED DEVICE CAN BE EXAMINED. DEVICE NOT RETURNED.

Description of Event or Problem

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.

Remedial action

  • Other