DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Description of Event or Problem

IT WAS REPORTED THAT A REVISION DUE TO NON-UNION WITH A BROKEN PLATE WAS PERFORMED ON (B)(6) 2015. THE ORIGINAL PROCEDURE, A REPAIR OF A PERIPROSTHETIC RIGHT FEMUR FRACTURE, WAS PERFORMED APPROXIMATELY A FEW MONTHS PRIOR TO THE REVISION DATE. THE PATIENT HAD SUSTAINED A FALL AFTER THE ORIGINAL PROCEDURE; XRAYS SHOWED THE NON-UNION BUT THE BROKEN PLATE WAS NOT CONFIRMED UNTIL THE REVISION PROCEDURE (THE PLATE APPEARED TO BE BENT IN THE X-RAYS). REMOVED HARDWARE INCLUDED A 12-HOLE PLATE (TEN OF THE TWELVE HOLES HAD BEEN FILLED WITH SCREWS; THE TWO MIDDLE HOLES OVER THE ORIGINAL FRACTURE SITE WERE LEFT OPEN - THIS IS WHERE THE BREAK IN THE PLATE OCCURRED). THE ORIGINAL COMPETITOR'S PROSTHESIS WAS REMOVED AND THE PATIENT WAS REVISED TO A NEW EXTENDED PROSTHETIC STEM, A PERIPROSTHETIC PLATE, TWO PERIPROSTHETIC SCREWS AND FOUR CABLES. NO SURGICAL DELAYS, NO FRAGMENTS, NO ADDITIONAL MEDICAL INTERVENTION REPORTED. THE REVISION WAS SUCCESSFULLY COMPLETED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).