MAUDE Adverse Event Report: SMITH AND NEPHEW HIP IMPLANT BIRMINGHAM

Model Number 74120150

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 09/01/2015

Event Type  Injury  

Event Description

I have the smith and nephew birmingham hip resurfacing in both hips.I began having extreme pain on the left side, from my hip to my knee.Not a single doctor here in (b)(6) has ever seen my implants so no one knows what's wrong.They don't even know if i can have an mri.Without insurance, i have had to do my own research and i've found that the implants in my body are 42mm, which, according to documents on line, are no longer allowed.These implants are excruciating.I am nearly bed ridden and i used a cane constantly.Walking is painful.My life has gone from active middle age to crippled old woman in a matter of 3 years.I can't work because i can't move without significant pain.Without a job, i have no healthcare.Without healthcare, i cannot get any medical treatment.Because of the excruciating pain, i am not working.I lost my home, my car and my ability to provide for myself.What's really scary is that texas doctors that i have been able to see, at the er, have no clue about these implants.I'm also sure that these metals are running together and flaking off into my blood as well as damaging tissue, thus causing the extreme pain, which no one will address at all.I am left here, cripple, without any way to resolve my situation.

• Brand Name: HIP IMPLANT BIRMINGHAM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 7472562
• MDR Text Key: 107023669
• Report Number: MW5076889
• Device Sequence Number: 2
• Product Code: NXT
• Combination Product (y/n): N
• 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: 04/16/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 74120150
• Device Catalogue Number: CUP ACETAB HIP 50 MM
• Device Lot Number: SHELL ACETABULAR BHR42LOG33099
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 52