FDA Adverse Event Injury Summary report: N

DEPUY PARTIAL KNEE 55MM

MDR report key: 3840175 · Received May 23, 2014

Report

Report Number
MW5036332
Event Type
Injury
Date Received
May 23, 2014
Date of Event
May 13, 2009
Report Date
May 19, 2014
Manufacturer
DEPUY
Product Code
JWH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE HAD 3 KNEE REPLACEMENTS SINCE (B)(6) OF 1999 ON MY RIGHT KNEE. THE FIRST ONE A DEPUY PARTIAL KNEE REPLACEMENT 55MM COLLAPSED INTO THE TIBIA IN (B)(6) 2005 AFTER 6 YEARS. A SECOND DEPUY ROTATING PLATFORM KNEE WAS INSTALLED IN (B)(6) 2005, THIS IMPLANT LOOSENED UP AT THE TIBIA COMPONENT AFTER 4 YEARS IN (B)(6) 2009. A 3RD DEPUY FIXED BEARING KNEE WITH EXTRA LONG STEM WAS INSTALLED IN (B)(6) 2010, THIS UNIT BECAME PAINFUL ONLY 3 MONTHS AFTER IT WAS INSTALLED. FINALLY THE FIXED BEARING IMPLANT WAS DIAGNOSED AS LOOSE AT THE FEMUR AND TIBIA BY MRI AND TRIPLE PHASE BONE SCAN IN (B)(6) 2013, THREE YEARS SINCE BEING INSTALLED. I WAS FINALLY ABLE TO FIND A DOCTOR AT (B)(6) THAT WOULD DO A 4TH REPLACEMENT KNEE IMPLANT, TO BE INSTALLED IN (B)(6) 2014. I HAVE HAD 3 DIFFERENT SURGEONS AT 3 DIFFERENT HOSPITALS INSTALL THESE IMPLANTS WHICH WERE ALL MADE BY DEPUY. DURING THE WINTER OF 2013, I REQUESTED THAT SAMPLES OF THE SYNOVIAL FLUID THAT WAS DRAWN FROM MY SWOLLEN KNEE BE TESTED FOR POLY ETHYLENE PLASTIC BREAK DOWN, THESE TESTS SHOWED THAT THERE WAS A LARGE AMOUNT OF POLY PLASTIC MATERIAL IN THE FLUID (DRAWN IN (B)(6) OF 2013), FLUID SAMPLES DRAWN ((B)(6) THERE WAS NO SIGNS OF POLY PLASTIC MATERIAL IN THE SAMPLES). I FEEL THAT THE POLY PLASTIC WAS BREAKING DOWN AND HAS NOW BEEN WORN OUT COMPLETELY FROM THE JOINT. OVER THE PAST 13 YEARS I HAVE UNDERGONE 12 ORTHOSCOPIC SURGERIES TO REMOVE BUILT UP SCAR TISSUE IN THE REPLACEMENT JOINTS, ALONG WITH OTHER TYPES OF PAIN RELIEVING PROCEDURES, SUCH AS PROLO THERAPY INJECTIONS, NERVE BLOCK IMPLANTS AND ACUPUNCTURE TREATMENTS WITHOUT ANY RELIEF. I HAVE BEEN ON CRUTCHES SINCE (B)(6) OF 2013, I HAVE BEEN UNABLE TO WORK AND I AM IN CONSTANT PAIN EVEN WITH PRESCRIBED PAIN MEDICATIONS. I AM UNDER THE CARE OF DR (B)(6) SINCE 2008. HE HAS REFERRED ME TO DR (B)(6) FOR THE NEXT REPLACEMENT SURGERY. I HAVE BEEN ADVISED OF THE COMPLICATIONS RELATED WITH THIS NEXT REVISION AND I HAVE EVEN DISCUSSED THE AMPUTATION OF MY RIGHT LEG ABOVE THE KNEE, ALSO THE POSSIBILITY OF FUSING MY RIGHT KNEE, THE DOCTORS HAVE ADVISED AGAINST THESE PROCEDURES. I HAVE NEVER BEEN CONTACTED BY ANYONE FROM DEPUY AND HAVE NEVER RECEIVED ANY COMPENSATION FROM DEPUY FOR ALL THE EXPENSES THAT I HAVE OCCURRED FOR ALL OF THESE SURGERIES. I WOULD APPRECIATE ANY HELP FROM THE FDA IN THE POSSIBILITY OF RESOLVING THE PROBLEMS THAT I HAVE ENDURED FROM THE IMPLANTING OF THESE PRODUCTS MADE BY DEPUY. THANK YOU, (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
307086 DEPUY PARTIAL KNEE 55MM KNEE REPLACEMENT JWH DEPUY
307087 DEPUY ROTATING PLATFORM KNEE KNEE IMPLANT JWH DEPUY
307088 DEPUY FIXED BEARING KNEE WITH EXTRA LONG STEM KNEE REPLACEMENT JWH DEPUY

Patients

Seq Age Sex Outcome Treatment
1 52 YR Disability