FDA Adverse Event Injury Summary report: N

BUECHEL-PAPPAS TOTAL ANKLE REPLACEMENT

MDR report key: 1047159 · Received May 19, 2008

Report

Report Number: MW5006925
Event Type: Injury
Date Received: May 19, 2008
Date of Event: November 1, 2007
Report Date: April 29, 2008
Manufacturer: ENDOTEC INC.
Product Code: KXC
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: NJ, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

AN ARTIFICIAL ANKLE JOINT FAILURE, RIGHT ANKLE CAUSING LARGE BONE CYSTS. THE PATIENT HAD A TOTAL ANKLE JOINT REPLACEMENT IN 1998. THE ANKLE WAS BECOMING MORE AND MORE PAINFUL AND SWELLING BEGINNING IN 2007. ON THREE MONTHS LATER, THE DOCTOR WHO DID THE ANKLE REPLACEMENT SURGERY, AFTER YEARS OF SILENCE, SENT THE PATIENT A LETTER TO COME TO THE OFFICE AND GET THE ANKLE CHECKED. THE X-RAYS MADE THAT DAY 11/2007 SHOWED SOME OF THE PROBLEM. THE PATIENT GOT A SECOND OPINION AND HAD ANOTHER SURGEON REPAIR THE ANKLE WHICH REQUIRED A COMPLEX FUSION. NOTE THAT THE MANUFACTURER AND THE SURGEON WHO DID THE ORIGINAL IMPLANT ARE ONE AND THE SAME. X-RAYS IN 12/2007 AND A CT SCAN IN 01/2008 REVEALED LARGE CYSTS ON THE BONE AND A BADLY WORN ANKLE JOINT THAT WAS OUT OF ALIGNMENT. THE ANKLE REQUIRED LENGTHY SURGERY TO REMOVE THE FAILED JOINT AND CYSTS, GRAFT CADAVER BONE AND FUSE THE JOINT. ADMITTED TO THE HOSPITAL ON THE FOLLOWING MONTH, RELEASED ON THREE DAYS LATER. THE PATIENT IS STILL UNABLE TO WALK AS OF THE FOLLOWING MONTH AND MAY NEVER BE ABLE TO WALK NORMALLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BUECHEL-PAPPAS TOTAL ANKLE REPLACEMENT	ANKLE REPLACEMENT	KXC	ENDOTEC INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R\| S	ATACAND 4MG PER DAY\| DIGOXIN 25MG PER DAY\| WARFARIN SOD 6MG PER DAY\| QUINAPRIL 40MG PER DAY\| METFORMIN 500MG PER DAY\| FUROSEMIDE 80MG PER DAY