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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY DEPUY PINNACLE; PROSTHESIS, HIP

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DEPUY DEPUY PINNACLE; PROSTHESIS, HIP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Date 01/04/2013
Event Type  Injury  
Event Description
To whom it may concern, i was diagnosed with moderate arthritis of the right hip in 2009.I was a stay-at-home mom of 4 daughters, not having worked since 1996 as an interviewer/phlebotomist for the (b)(6) breast cancer study project.Before that, i was a technical specialist for the dept.Of surgery, transplantation service at (b)(6).During my years at home i worked part time, drafting landscape designs for my brother-in-law.On (b)(6) 2012 i had my right hip replaced at (b)(6).My arthritis was too severe for any other options.While recovering in the hospital, i had swelling and bruising from hip to knee.The knee was also very painful.I suspected something was not right, but was assured everything was normal.I believe my new hip displaced while being discharged, getting into the wheelchair in my hospital room, with the rn standing behind the chair.I yelled in pain, then stood up, and the pain was gone.I was sent home, where a lot of people took care of me.I skipped my 2-3 week wound check, which delayed my recovery.On (b)(6) 2013 i had my right hip repaired at (b)(6).When i was admitted the day before and taken to my room, the nurse who discharged me was waiting there, in plain clothes.She apologized to me, and hoped i had a nice holiday.I met with attorney (b)(4) just a few weeks later.He was familiar with my case because he said my surgeon's namer before i did.After telling him what happened, he advised that i should not be the first person to sue dr.(b)(6) because "no other doctor will touch you".He then said it will cost about (b)(4) to bring a case, which is the same amount i would win.That didn't sound right to me and i asked him if that amount was low because i'm just a housewife.He shook his head, yes.I'm a little blurry about what happened next.As i got up to leave he told me to get the hospital records for both surgeries.After sending mr.(b)(4) my records, his associate called me and said it would not be a good business decision for them to proceed.I spoke with another lawyer who also asked for my records.I sent them, but he never got back to me.The most important thing i learned from my medical records is that i had mild arthritis of the left hip, not previously diagnosed.I also learned i have cobalt in my body.It has been 4 years and the arthritis in my left hip is quite worse, but i will not have it replaced.My right hip is holding up, but i can't lean on it for long without pain.And when standing or walking too long, the skin from hip to knee burns, like sunburn.I was told this is permanent.I also have had symptoms of dvt in my right leg, as well as melanoma just recently, on the right leg.I have had many health issues since my surgeries, complicated by another separate incident.Starting in 2011 i was prescribed metoprolol tartrate 25 mg tabs for high blood pressure.I suspect these pills were harmful to me because i became very sick, around (b)(6) 2013.Symptoms were increasing pain in the back and right side, and dangerously high blood pressure.I was sent for a ct scan which ruled out kidney stones, and i was diagnosed with fatty liver disease at that time.I suspect this prescription may have harmed my liver.I was also referred to other specialists due to abnormal bloodwork.Symptoms went away after stopping the medication, manufactured by (b)(4) and dispensed by (b)(4).My family has been severely impacted financially due to increased medical expenses and decreased income.We have good medical insurance now, but copays are numerous for the family, and insurance may not always be available, as my husband's job is not secure.My husband, (b)(6), was fired from (b)(4) as the service coordinator on (b)(6) 2015 after 2 years of harassment at his workplace by (b)(6) during our loan modification process (we fell a little behind while i was ill because of the lack of overtime for (b)(6) while caring for me).He was unemployed for 10 days and had to take a lower paying job ((b)(4) less annually).
 
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Brand Name
DEPUY PINNACLE
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
DEPUY
MDR Report Key6525583
MDR Text Key73953050
Report NumberMW5069355
Device Sequence Number1
Product Code JDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
EMBALTEC.; LIPITOR; OTC MEDS: NONE.; RX MEDS: METOPROLOL TARTRATE
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age55 YR
Patient Weight59
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