MAUDE Adverse Event Report: KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Abdominal Distention (2601); Cancer (3262)

Event Date 11/04/2021

Event Type  Death  

Event Description

My husband was (b)(6).Had been seeing the same doctors for high blood pressure, diabetes, and high cholesterol for the past 15 yrs at least.He always kept his appointments, always took his medications like clockwork, always took his blood test every 3 months, or whenever he was told to.Then would follow up with the doctor appointments.He'd never cancel, unless it was an honest oversight.So he was, i'd say definitely under several doctors care for a minimum of 15 yrs.My husband was never sick.He was put on metformin for all of these years, and approximately 4 months or so ago that was replaced with trulicity for diabetes.Around (b)(6), of this year, we made an appointment with his gastrointestinal doctor because my husband couldn't have a bowel movement and his stomach seemed to be growing larger and harder.We thought maybe he was constipated and possibly had an intestinal blockage; thinking the doctor might give him a good enema.But this doctor told my husband that yes he had a hard stomach, it was a blockage, told him to go home and take some miralax, come back in one month for a colonoscopy.2 days later the pain was so bad, i had to take him into the er.He still hadn't had a bowel movement.With that er visit, the doctor told us after a few test and bloodwork that my husband did not have a blockage but had "a belly full of stage 4 pancreatic cancer that had metastasized".Still, we were sent home and 2 days or so later that pain was so excruciating, we ended back up in the er, where they then decided to admit him.They stuck him with every needle, had him on morphine, fentenol, dillotid; they ended up putting a port, a ventilator, you name it on him with stool softeners and catheters.He still got worse and worse.These doctors never tried any of the newer experimental progressive drugs.Instead, he was treated as if he was just going to die and there was nothing they could do.I never left his side; and after about 2 weeks in that hospital, my husband died on (b)(6) 2021, from this metastasized pancreatic cancer, stage 4.How could something like this happen while under several doctors care.When these doctors know these drugs cause cancers? instead, they continually prescribe these medicines to older people and never even check for cancers in the body.Not one test saw anything that might tip them off! stage 4 pancreatic cancer that had metastasized.This is just wrong.I had to write this for someone to know about how doctors can prescribe a medication they know can cause a deadly disease yet never check for the deadly disease? i want it known what these doctors were negligent starting 15 years ago with the prescriptions, then with the misdiagnosis of the intestinal blockage, to the er sending my husband home in pain, to this automatic acceptance that he was going to die.I'd like to add; my husband was allergic to nickel and had a knee replaced with a replacement that left him with a stiff leg.He also had had prostate cancer that was treated with seed implants and supposedly there was no more cancer there.Coming to las vegas, these doctors seem negligent, quick to operate and put you on medications.Where do i go from here? please help me.Please contact me.I can get test results, or anything you need.I don't know the names or results of all of the test but they can be gotten.Under their care, other than prostate cancer that was treated with seed implants and cured 13 yrs ago.Kept up with urology appts.To insure it never came back.Had a knee replacement, was allergic to nickel so had to have a porcelain one.His leg never was able to be used again, it remained stiff after weeks of therapy.His main issue was being diagnosed with stage 4 metastasized pancreatic cancer on (b)(6) 2021 after being on metformin for 15 yrs, then put on trulicity.After seeing these specialized doctors and having regular blood work for 15 yrs? how is it, not one blood test or specialized doctor noticed one issue with cancer in not one of his organs? the drugs he was placed on should have caused reason to keep an eye out for cancer.You'd think.Considering he was fine leading up into october.Upon going to see the gastroenterologist thinking he had an intestinal blockage, this doctor sent him home confirming the intestinal blockage and told him to take some miralax and come back in a month for a colonoscopy.My husband was diagnosed less than 5 days later with metastasized pancreatic cancer and was dead in 2 weeks.Starting with the doctors who prescribed the metformin and trulicity, then all the doctors not finding any cancer, then the gastro., doc that sent him home, then the er doc., in the hospital that sent him home, then the automatic assumption he was going to die with not at least trying to use experimental drugs.Everyone past the buck or was just negligent.What would you do? fda safety report id# (b)(4).

• Brand Name: KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• MDR Report Key: 13024702
• MDR Text Key: 282419576
• Report Number: MW5106115
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; BABY ASPIRIN ; DORIZOLAMIDE HELP ; METFORMIN ; OLMASARTAN ; TRULICITY; VEHICLE; VIT C ; VIT D; VYZULTA
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Hispanic
• Patient Race: Asian, Black Or African American