MAUDE Adverse Event Report: SMITH AND NEPHEW ORTHOPAEDICS AG R3 ACETABULAR SOCKET; PROSTHESIS, HIP

Device Problems Material Fragmentation (1261); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Bacterial Infection (1735); Diarrhea (1811); Emotional Changes (1831); Hearing Loss (1882); Failure of Implant (1924); Neurological Deficit/Dysfunction (1982); Pain (1994); Thyroid Problems (2102); Tinnitus (2103); Loss of Vision (2139); Vomiting (2144); Tingling (2171); Anxiety (2328); Depression (2361); Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2019

Event Type  Injury  

Event Description

In (b)(6) 2012 a smith and nephew birmingham hip resurfacing implant was installed in my left hip.Begin in (b)(6) 2015 i began to develop major health issues including: left hip pain, popping and clunking in the left hip joint, extreme depression, anxiety, unable to control mood swings, tingling in hands and feet, ringing in ears, vision loss, hearing loss, vomiting, diarrhea plus many more unexplained symptoms.By (b)(6) 2017, i was committed to a psych ward in the hospital.It wasn't until i was released 10 days later that i realized something inside of me was responsible for my illness.I then was unable to sleep at night, memory loss, confusion, had dementia symptoms, extreme anxiety, depression, inability to make sense of anything, massive pain, my thyroid went 5 times under active, unable to control blood sugar levels, more vomiting and diarrhea daily, so many symptoms! it wasn't until (b)(6) 2018 i began doing massive research to find what was killing me as i felt i was running out of time and dying!.I then began to believe that i had metal toxicity from both of my metal hips from smith and nephew.After a blood test, i discovered my chromium level was 53.3 (should have been less than.03) and cobalt level at 43 (should have been less than.09).I was finally able to find a doctor able and qualified to save my life at (b)(6) clinic! my left birmingham hip resurfacing implant was removed in (b)(6) 2019, due to metal toxicity and prosthetic loosening.My right smith and nephew recalled acetabular r3 implant was removed in (b)(6) 2019.The damages in the right hip were extensive due to the massive metal debris.I developed a pseudo, tumor, which absorbed the metal toxicity, lost over 50% of my right hip muscles, developed a staphylococcus bacterial infection, suffered a hip dislocation (due to the massive muscle loss) and have spent 30 days hospitalized since (b)(6) 2019.Due to the massive damage, i've had to have 3 hip revisions on the right hip this year.My doctor said i'm looking at 16 months of physical therapy just to regain strength and avoid future dislocation.I'll tell you, there is no greater pain than a dislocation! nothing! not even childbirth without medication! because of the 4 1/2 year battle to stay alive recover, i've not only lost my job, my retirement, my health insurance, the metal toxicity took my period away and put me in menopause at the age of 45.I am unable to work because i cannot remember anything, my vision and hear are so poor and i was robbed of the last four years being a mother to my children, as their father passed away 4 years ago! fda safety report id # (b)(4).

• Brand Name: R3 ACETABULAR SOCKET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): SMITH AND NEPHEW ORTHOPAEDICS AG
• MDR Report Key: 8655045
• MDR Text Key: 146903327
• Report Number: MW5086994
• Device Sequence Number: 2
• Product Code: MEH
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 61