FDA Adverse Event Injury Summary report: N

SMITH + NEPHEW

MDR report key: 3010728 · Received March 12, 2013

Report

Report Number
MW5029381
Event Type
Injury
Date Received
March 12, 2013
Date of Event
April 27, 2004
Report Date
March 12, 2013
Manufacturer
SMITH & NEPHEW
Product Code
JDI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
ID, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

HAD TOTAL LEFT HIP ARTHROPLASTY IN (B)(6). PERFORMED AT (B)(6) HOSP. MFR OF TOTAL HIP REPLACEMENT IS SMITH & NEPHEW. TYPE OF DEVICE: LEFT TOTAL HIP ARTHROPLASTY SMITH & NEPHEW. DEVICE EVENT DATE: (B)(6) 2004. ABOUT 3 YEARS AGO, I BEGAN HAVING MINOR PAIN IN THE SURGERY AREA, AND DIMINISHED MOBILITY FEELING THAT HIP IS GIVING OUT LEADING TO A FALL. I CALLED THE SURGEON WHO PERFORMED THE ARTHROPLASTY DR (B)(6) TO FIND OUT IF THERE WAS A RECALL INVOLVING MY IMPLANT. I WAS NEVER ALLOWED TO BE ABLE TO SPEAK DIRECTLY TO DR (B)(6), AND HIS OFFICE MANAGER TOLD ME "SHE HAD NO RECORD OF ME EVER BEING SEEN, OR OPERATED ON BY DR (B)(6). I THEN REQUESTED IN WRITING FROM THE MEDICAL RECORDS DEPARTMENT AT (B)(6) HOSP IN (B)(6), ALL MY RECORDS INVOLVING MY SURGERY AND STAY. INTERESTINGLY, AFTER I RECEIVED THIS, DR (B)(6)'S OFFICE FOUND THE OPERATIVE REPORT FROM THE DOCTOR, AND FORWARDED ME A COPY. OVER THIS TIME PERIOD, I AM EXPERIENCING INCREASING PAIN AND DISCOMFORT NOW ON A PERMANENT BASIS AND MORE EPISODES OF THE HIP REPLACEMENT GIVING OUT. AS OF THIS DATE, I HAVE NOT HAD ANY BLOOD, OR RELATED TESTS PERFORMED TO CHECK FOR METALLOSIS DUE TO COBALT OR CHROMIUM POISONING, AND OR TUMOR GROWTH AS I DO NOT KNOW WHICH SPECIFIC TESTS TO REQUEST. MY RESEARCH HAS SHOWN THAT THESE SMITH & NEPHEW HIP REPLACEMENTS, AND SEPARATE COMPONENTS HAVE INDEED BEEN RECALLED, AND TESTS HAVE PROVEN INCIDENTS OF METALLOSIS AND TUMORS, AS WELL AS FAILURES OF THE SYSTEM. I HAVE ESSENTIALLY RUN INTO A DEAD END WITH MY SURGEON, AND RESPECTFULLY REQUEST HELP IN HELPING ME FIND MY OPTIONS IN CORRECTING THIS PROBLEM, THANK YOU, (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
104462 SMITH + NEPHEW HIP JDI SMITH & NEPHEW

Patients

Seq Age Sex Outcome Treatment
1 50 YR Life Threatening| O| R