MAUDE Adverse Event Report: SMITH AND NEPHEW BIRMINGHAM HIP; HIP IMPLANT

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Hearing Loss (1882); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Optical Nerve Damage (1986); Pain (1994); Paralysis (1997); Scar Tissue (2060); Swelling (2091); Ulcer (2274); Discomfort (2330); Complaint, Ill-Defined (2331); Chemical Exposure (2570); Test Result (2695)

Event Type  Injury  

Event Description

In (b)(6) 2007, i had the birmingham hip made by smith and nephew implanted in my right hip for problems related to hip dysplasia.It was described to me as the solution that would last for 20-30 years.Fast forward to (b)(6) 2013: after several years of pain and discomfort in my right hip, i returned to my surgeon to find out what was wrong.(i know, most people wouldn't have put up with the discomfort for so long, but i also have fibromyalgia and assumed my issues were related to that.After all, it couldn't have been my hip, it was supposed to last 30 years!) test results showed pseudotumors, elevated blood levels of cobalt and chromium, and possible infection.(b)(6) 2014 was my first surgery to remove the birmingham hip.Surgeon found massive infection related to nickel allergy.Didn't know i was allergic to nickel.Had prostelac implanted.Following with 6 weeks of both iv and oral antibiotics.Early (b)(6) 2014 i had a ceramic hip made by biometric implanted.My hip has healed.I'm now left with scar tissue ( a result not only of the surgery, but of all the scraping that needed done due to infection and damage from cobalt and chromium) that is encasing my femoral nerve causing functional paralysis of most of my right leg.Hopefully this is not permanent.Don't know yet.Is there a reason i was not notified by the fda, or my surgeon, or event the manufacturer when it became known that the metal on metal devices were causing problems and having a high failure rate? it would have made sense to me for someone to notify the patient.Maybe if i had been notified, i wouldn't have developed problems with my optic nerve.Or maybe my hearing wouldn't have gone so downhill.Or maybe i wouldn't have developed problems with my optic nerve.Or maybe my hearing wouldn't have gone so downhill.Or maybe i wouldn't have developed the ulcer.Or digestive issues.Or high blood pressure.All medical problems that could be related to metal poisoning.Obviously the pre-market testing done by smith and nephew was flawed.Their metal on metal products are failing as often as dupuy, etc.But they apparently don't have to show any responsibility due to a pre-emptive status with the courts based on the pre-market approval by the fda.Approval based on flawed testing.So anyway, please be advised of one more failure of the birmingham hip and adjust your numbers accordingly.Also, please consider creating a system of notifying patients when problems arise with medical devices.

• Brand Name: BIRMINGHAM HIP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 3972794
• MDR Text Key: 4627386
• Report Number: MW5037518
• 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: 07/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 70