MAUDE Adverse Event Report: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING

Device Problem Noise, Audible (3273)

Patient Problems Lupus (1956); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Toxicity (2333)

Event Date 08/05/2013

Event Type  Injury  

Event Description

I am a male age (b)(6).On (b)(6) 2007 i had a birmingham hip resurfacing procedure done.All follow ups were completed with surgeon to include x-rays and check ups.In 2011, i was bothered by a red spot on my left eye and consulted my primary as well as an ophthalmologist.Bloodwork showed increased ana levels of 1:640 h.I then was referred to a rheumatologist that treated me for lupus symptoms with plaquenil.This did not help so we stopped the drug.In (b)(6) 2012, i noticed my left hip device was squeaking and grinding significantly.I researched what the device was made of and asked my primary to order bloodwork for chromium and cobalt.On (b)(6) 2013 my bloodwork revealed a cobalt reading of 50.9, significantly higher than the 0.1-0.4 mcg/l range.My chromium levels were 56.7, much higher than the 1.4 mcg/l reference range.I immediately made an appointment with my surgeon at (b)(6), dr (b)(6).He performed an x-ray and noted that the device was in a good place, but it had to come out and be replaced since my bloodwork was showing such severe levels of metal.Revision surgery was scheduled for (b)(6) 2013.In (b)(6), i noticed sensational pain in my left hip and leg.I had notable stiffness and discomfort and called (b)(6) office to see what could be done.I was prescribed a painkiller to get me through the summer until the date of the surgery.Surgery was completed and i had blood levels checked on (b)(6) 2013.Cobalt was down to 5.1 from the previous 50.9 and chromium was down to 14.0 from the previous 56.7.My eyes seemed clear and less dry and my overall state of health and well being seemed much more stable, even though i had not recognized that it had been altered prior to the revision.

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: BIRMINGHAM HIP RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW
• MDR Report Key: 3670347
• MDR Text Key: 19920625
• Report Number: MW5034852
• Device Sequence Number: 1
• Product Code: NXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 84