FDA Adverse Event Injury Summary report: N

BIRMINGHAM HIP RESURFACING

MDR report key: 2792458 · Received October 10, 2012

Report

Report Number
MW5027235
Event Type
Injury
Date Received
October 10, 2012
Report Date
October 10, 2012
Manufacturer
SMITH & NEPHEW CORP
Product Code
NXT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
DC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2007, I HAD HIP RESURFACING SURGERY ON THE LEFT SIDE BY DR (B)(6) OF (B)(6). THE SURGEON USED A BIRMINGHAM SURFACE REPLACEMENT. DURING THE FIRST WEEK IN(B)(6) 2012, I BEGAN HAVING SHARP SEVERE PAINS IN MY LEFT HIP, THIGH, AND GROIN AREAS. INITIALLY I BELIEVED THAT THIS WAS THE RESULT OF A COMBINATION OF RIGOROUS PROFESSIONAL TRAVEL SCHEDULE INVOLVING FLIGHTS BETWEEN (B)(6) AND (B)(6), MANY HOURS OF BUMPY SUV TRAVEL THROUGH RURAL AREAS, INCLUDING UNPAVED ROADS, BEGINNING NEW EXERCISES WITH MY PERSONAL TRAINER, AND FATIGUE. ON (B)(6) 2012, I VISITED THE SURGEON TO DISCUSS THIS PAIN. HE EXAMINED AN X-RAY TAKEN THAT DAY BY HIS OFFICE STAFF, COMPARED IT TO PAST POST-SURGERY X-RAYS, AND SAID THAT HE BELIEVED THAT PAIN RESULTED FROM SEVERE MUSCLE STRAIN, ADVISED ME TO REST, TAKE ALEVE, AND CONTACT HIM AGAIN IN 2 WEEKS IF THE PAIN PERSISTED. I VISITED DR (B)(6) OFFICE AGAIN. HE SAID THAT MY IMPLANT MIGHT BE LOOSENING AND THIS MIGHT LEAD TO ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT. HE ALSO INDICATED THAT THIS MAY REQUIRE REVISION SURGERY, A COMPLETE HIP REPLACEMENT. HE ORDERED A WHOLE-BODY BONE SCAN AND BLOOD TESTS FOR COBALT AND CHROMIUM. THE BONE SCAN, PERFORMED ON (B)(6) 2012, STATED, "THERE IS INCREASED UPTAKE [OF ISOTOPE] IN THE LEFT HIP ON ALL THREE PHASES. THIS IS BEST SEEN ON THE DELAYED STATIC IMAGES AND APPEARS TO PRIMARILY INVOLVE MOST OF THE UPPER LEFT FEMORAL HEAD NEAR THE ACETABULUM. THERE IS ALSO A SMALL FOCUS OF INCREASE UPTAKE NEAR THE GREATER TROCHANTER. THE SCINTIGRAPHIC PATTERN IS NONSPECIFIC. PROSTHETIC LOOSENING CANNOT BE EXCLUDED." THE SEVERE PAIN IN THIS AREA PERSISTS AND I AM CONFERRING WITH OTHER SURGEONS ABOUT OPTIONS. PT FOLLOWING SURGERY IN 2007, PERSONAL TRAINER TWO TIMES WEEKLY - UNTIL SEVERE PAIN BEGAN IN (B)(6) 2012; RESTARTED VERY LIGHTLY IN EARLY (B)(6) 2012 PSYCHOTHERAPY (TWICE MONTHLY) AND SERTRALINE 150MG/DAY, SEIZURE DISORDER: KEPPRA 3000MG/DAY AND LAMICTAL 600 MG/DAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BIRMINGHAM HIP RESURFACING BHR NXT SMITH & NEPHEW CORP BHR SYSTEM

Patients

Seq Age Sex Outcome Treatment
1 53 YR Required Intervention