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 IncModel number
17044Catalog 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