MAUDE Adverse Event Report: SMITHS AND NEPHEWS, INC. R3 ACETABULAR CUP, OXINIUM BALL, BIRMINGHAM HIP SYSTEM; PROSTHESIS, HIP SEMI-CONSTRAINED, UNCEMENTED METAL/POLYMER, POROUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Blurred Vision (2137); Anxiety (2328); Depression (2361); Sleep Dysfunction (2517); Ambulation Difficulties (2544); No Code Available (3191); Constipation (3274)

Event Date 09/28/2012

Event Type  Injury  

Event Description

After injuring my left hip in (b)(6) 2012 and going through physical therapy for 3 months, it was determined that i would need a total hip replacement.I had surgery to replace my hip in (b)(6) 2012.The manufacturer is smith & nephew, the hip has an oxinium ball with an r3 acetabular cup and a birmingham hip system.My recovery was long and grueling and after two years and going through constant physical therapy, i was still unable to return to work.I¿m in excruciating pain when i sit.My primary doctor said that it was likely i¿d have to deal with chronic pain the rest of my life.I was only (b)(6) when this all started.I filed for disability in the state of (b)(6) and had no problem receiving it after the doctors reviewed my medical records, examined me and i spoke with a psychologist.Since i have had this implant, i have tried everything to relieve the pain, including several nerve ablations, caudal blocks, steroid injections and a multitude of medications.Even with the strongest of opioids, i still have a lot of agonizing breakthrough pain.I spend many days immobilized due to the pain.I've liquidated my retirement, and my financial resources have dwindled down to nothing.I was told over and over that there were no other complaints with this hip.I consulted with at least four other orthopedic surgeons who told me there was no nickel in any of the components.After doing my own research, i found nickel in the oxinium ball made by smith & nephew.I've had an allergy to nickel since i was a child, but no one asked about it prior to surgery.Half of the orthopedic surgeons said to replace it, the other half said to leave it alone.One said if i did revise it, that it could be worse, it could be better or it could be the same and there are no guarantees, plus i will lose more bone.I have worked for major corporations throughout my life.Some of the positions i held were as a (b)(6), a (b)(6) and as one of two people who managed a subsidiary of a company.I served on the executive board of directors for (b)(6) and volunteered for many worthy causes.I received awards at every company i worked for.I had to resign from my last position and miss working.Now, even without medication, my memory is foggy at times, i'm at a loss for simple words, i've experienced ongoing heart palpitations, anxiety, depression, constipation, blurred vision, sleeplessness and my family has noticed personality changes where i don't have much patience anymore.I also have leg-length discrepancy where one leg is longer than the other and have to wear shoes with a lift at all times.I'm currently considering a spinal cord stimulator to help block the pain in my hip but i'm concerned about having another medical device put in my body.This has completely turned my life upside down.I left my family and lifelong friends and moved from (b)(6) to (b)(6) in hopes that warmer weather would help alleviate my constant pain.I believe that because i can be more mobile in the winter, it has helped with depression and mobility but hasn't done much for the pain.I am extremely frustrated that i was not informed of the risks associated with putting metal in my body nor a check to see if i was allergic to nickel by any medical professionals.I am to the point where i want this out of my body but it¿s not as simple as just having it removed and revised, it is a long and grueling recovery.I had a prescription written that i would have a lifetime need for a walker and only by hiring a personal trainer myself was i able to move away from a walker and then to a cane that i have to use on the days where my balance is compromised.By reporting this, i hope my government starts protecting us from faulty medical devices.I implore you to investigate and require testing for all medical devices that are currently on the market.Some devices that are on the market will ruin many more lives.

• Brand Name: R3 ACETABULAR CUP, OXINIUM BALL, BIRMINGHAM HIP SYSTEM
• Type of Device: PROSTHESIS, HIP SEMI-CONSTRAINED, UNCEMENTED METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITHS AND NEPHEWS, INC.
• MDR Report Key: 8248452
• MDR Text Key: 133519663
• Report Number: MW5083086
• Device Sequence Number: 1
• Product Code: KWA
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Disability
• Patient Age: 54 YR
• Patient Weight: 86