FDA Adverse Event Injury Summary report: N

DEPUY ROTATING PLATFORM SYSTEM

MDR report key: 2163549 · Received July 7, 2011

Report

Report Number
MW5021307
Event Type
Injury
Date Received
July 7, 2011
Date of Event
August 29, 2006
Report Date
July 7, 2011
Manufacturer
JOHNSON & JOHNSON
Product Code
JWH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2006, I UNDERWENT A TOTAL RIGHT KNEE ARTHROPLASTY THROUGH (B)(6) IN (B)(6). THE COMPONENT USED ON MY KNEE IS A DEPUY PFC ROTATING PLATFORM SYSTEM. THE FEMUR WAS A SIZE RIGHT 4. THE TIBIA WAS A SIZE 3 MTB. THE INSERT WAS A SIZE 4, ROTATING PLATFORM, AND POSTERIOR STABILIZED 10MM. THE PATELLAS WAS A 35 -MM DOMED PATELLA. FROM THE BEGINNING, I FELT SOMETHING WAS INTERNALLY WRONG WITH MY KNEE. THE SURGERY WAS EXTREMELY DIFFICULT ON ME. IT IS NOW FIVE YEARS LATER, AND I CONTINUE TO EXPERIENCE SWELLING ON A DAILY BASIS ALONG WITH SIGNIFICANT RESTRICTION IN RANGE OF MOTION AND ONGOING PERSISTENT PAIN OVER THE MEDIAL AND LATERAL ASPECT OF MY KNEE. I HAVE HAD SEVERAL PHYSICAL THERAPY SESSIONS THAT HAVE BEEN UNSUCCESSFUL. I ALSO HAD A MANIPULATION ON (B)(6) 2006 THAT WAS ALSO UNSUCCESSFUL. TO DATE MY RIGHT KNEE IS RANGING BETWEEN 45-55 DEGREES. THEY CAN ALSO FEEL THE POLY RUBBING IN THE FEMORAL TROCHLEA. I HAVE CONSULTED WITH DOCTORS IN (B)(6), WHO FEEL THERE IS SOMETHING WRONG WITH THE COMPONENT IN MY KNEE. I LIVE WITH EXTREME ON-GOING PAIN EVERY DAY. I WENT ON-LINE AND FOUND THE FDA WARNING TO DEPUY KNEE REPLACEMENT PRODUCT WHERE I FOUND 100'S OF OTHERS LIKE MYSELF WHO HAVE PROBLEMS WITH THE DEPUY KNEE REPLACEMENT. I BELIEVE THIS PRODUCT NEED TO BE THROUGHLY INVESTIGATED. TOO MANY PEOPLE WITH THE SAME COMPLAINTS IS SUSPECT. PLEASE LET ME KNOW WHERE THE FDA STANDS ON THIS ISSUE. THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DEPUY ROTATING PLATFORM SYSTEM KNEE REPLACEMENT JWH JOHNSON & JOHNSON DEPUY PFC ROTATING

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention