FDA Adverse Event Injury Summary report: N

WRIGHT PROFEMUR

MDR report key: 2994282 · Received March 1, 2013

Report

Report Number
MW5029238
Event Type
Injury
Date Received
March 1, 2013
Date of Event
April 12, 2008
Report Date
March 1, 2013
Manufacturer
WRIGHT MEDICAL
Product Code
JDI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I UNDERWENT A HIP REPLACEMENT IN (B)(6) 2008 AND THE DEVICE IMPLANTED WAS A PROFEMUR WRIGHT PRODUCT. I IMMEDIATELY STARTED TO HAVE PAIN AND WAS SEEN BY FIVE DIFFERENT ORTHOPEDIC SURGEONS TO DETERMINE THE CAUSE OF THE PAIN. IN EACH CASE, THE HIP WAS X-RAYED AND WAS PROCLAIMED JUST FINE. FORTUNATELY ON A VISIT TO THE FIFTH SURGEON IN A PERIOD OF 18 MONTHS, THE SURGEON ORDERED AN ULTRASOUND. THE ULTRASOUND SHOULD IMMENSE AMOUNT OF FLUID IN AND AROUND THE HIP CAPSULE. THE FLUID WAS EXTRACTED AND WAS FOUND TO BE CLOUDY IN APPEARANCE. IT WAS DETERMINED AFTER LABORATORY ANALYSIS THAT I HAVE ALVAL. TWO MONTHS LATER, I UNDERWENT A REVISION WHERE PART OF THE PROSTHESIS- THE ACETABULAR CUP- WAS REPLACED WITH A CERAMIC CUP. IT WAS ASCERTAINED DURING SURGERY THAT THERE WAS STILL A LOT OF FLUID, THE TISSUE AROUND THE PROSTHESIS WAS NECROTIC AND THE GLUTEUS HAD BEEN TORN FROM THE BONE- SIMILAR TO A ROTATOR CUFF INJURY OF THE SHOULDER- SIX WEEKS AFTER THIS SURGERY, I EXPERIENCED 3 DISLOCATIONS AND WAS ADMITTED TO THE HOSPITAL FOR A THIRD SURGERY. DURING THIS SURGERY A CONSTRAINED LOCKING LINER WAS PLACED TO PREVENT FURTHER DISLOCATIONS. I STILL WALK WITH A TERRIBLE LIMP AND AM STILL IN PHYSICAL THERAPY. I AM APPALLED THAT THE WRIGHT MEDICAL PROSTHESIS HAS NOT BEEN RECALLED SINCE ITS FDA APPROVAL WAS "PIGGYBACKED" ON THE DEPUY DEVICE THAT HAS BEEN RECALLED. I AM MARRIED TO A JOHNS HOPKINS TRAINED THORACIC SURGEON BY THE WAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
89450 WRIGHT PROFEMUR PROFEMUR HIP REPLACEMENT DEVICE JDI WRIGHT MEDICAL

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization| L| R