BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO
Received Nov 30, 2018 · Event occurred Oct 9, 2015
Report MW5081760 · MDR key 8124666
Device
Product problems
- Loose or Intermittent Connection
Patient
58 YR
- Pain
- Joint Swelling
- Impaired Healing
- Pain
- Joint Swelling
- Impaired Healing
Narrative
Description of Event or Problem
HAD JOINT REPLACEMENT SURGERY ON MY RIGHT FOOT BIG TOE. JOINT WAS REMOVED AND THE PROCEDURE PERFORMED WAS A KELLER ARTHROPLASTY WITH BIOPRO IMPLANT RIGHT HALLUX WITH LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOOT. AFTER SURGERY HEALING DID NOT PROGRESS AS EXPECTED. MY CONDITIONED WORSENED WITH CONTINUOUS SWELLING. PHYSICAL THERAPY AND STEROIDS WERE TEMPORARILY HELPFUL. I HAD TO WEAR A SHOE THAT WAS A SIZE AND A HALF LARGER THAN MY LEFT BECAUSE OF CONTINUED SWELLING AND PAIN. AFTER A YEAR WITH NO RELIEF OR IMPROVEMENT I HAD TO HAVE SURGERY TO REMOVE THE IMPLANT IN (B)(6) 2016. THE FINDINGS OF THE SECOND SURGERY WERE LOOSE HARDWARE. THE MANUFACTURER OF THE DEVICES USED WERE PARAGON FOR THE SCREWS 3.0 X 16MM AND 3.0X14MM CANNULATED SCREWS AND BIOPRO IMPLANT SERIAL #(B)(4) LOT #116620. I WOULD LIKE TO KNOW IF THERE ARE ANY OTHER COMPLAINTS OF FAILURE OR RECALLS ON THIS DEVICE. I AM STILL HAVING ISSUES EVEN AFTER REMOVAL AND MAY HAVE TO HAVE A 3RD SURGERY.