FDA Adverse Event Other Summary report: N

BIOMET

MDR report key: 2224436 · Received August 17, 2011

Report

Report Number
MW5021860
Event Type
Other
Date Received
August 17, 2011
Date of Event
August 7, 2010
Report Date
August 17, 2011
Manufacturer
BIOMET
Product Code
KWB
Report Source
Voluntary report
Reporter Location
MT, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I AM PUTTING THIS IN WRITING. ON (B)(6) 2010, MY HUSBAND CALLED FROM THE LIVING ROOM. I WAS IN MY KITCHEN AND AS I TURNED TO SEE WHAT HE NEEDED, I FELT MY HIP REPLACEMENT SLIP OUT OF THE JOINT. I COULD HEAR MY FEMUR CRACKING. AT THAT TIME I LET MYSELF DOWN TO THE FLOOR AND WE CALLED 911. DOCTOR (B)(6) PERFORMED SURGERY TO REPLACE THE HIP AND TO REPAIR THE SPIRAL FRACTURE OF MY FEMUR. AFTER A STAY AT (B)(6) NURSING HOME AND SOME THERAPY I WENT HOME. IN EARLY (B)(6) DR. (B)(6) SAID THAT I COULD START PUTTING SOME WEIGHT ON IT, WHILE USING A WALKER. AFTER A FEW DAYS I COULD SEE THAT MY LEG WAS BENDING SO I WENT IN FOR AN XRAY. IT SHOWED THAT THE ROD THAT WAS PUT IN HAD BROKEN AND HAD REBROKEN THE FEMUR. I WAS IMMEDIATELY PUT INTO THE HOSP. DR. (B)(6) THEN DID SURGERY TO REPLACE THE ROD AND REPAIR THE FEMUR. AT THIS TIME, HE ALSO DID A BONE GRAFT TO FURTHER STRENGTHEN THE FEMUR AND TO PROMOTE BONE GROWTH. THE ROD BROKE ON (B)(6). I HAVE BEEN WALKING ON IT WHILE USING A WALKER, SINCE LATE (B)(6) AND SO FAR IT IS HEALING SUCCESSFULLY. I AM FILING THIS COMPLAINT BECAUSE OF THE FAILURE OF THE ROD THAT WAS USED. I FEEL THAT WHEN SOMETHING LIKE THAT IS PUT INTO YOUR BODY IT SHOULD LAST MY LIFETIME. I HAVE SUFFERED PAIN, MENTALLY AND CERTAINLY PHYSICALLY. ALSO WE LIVE ON A SMALL FIXED INCOME AND THE OUT OF POCKET EXPENSES HAVE BEEN A TERRIBLE BURDEN. AS FAR AS AN ADDRESS FOR THE PRODUCTS USED, I WOULD CERTAINLY HAVE TO BELIEVE THAT THE HOSP AND OR THE DOCTORS KNOW WHO THEY GET THEIR PRODUCTS FROM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIOMET HIP KWB BIOMET
2 SYNTHES PLATE HRS SYNTHES

Patients

Seq Age Sex Outcome Treatment
1 77 YR