MAUDE Adverse Event Report: STRYKER STRYKER METAL ON METAL RESURFACING; HIP RESURFACING IMPLANT

Device Problem Device Slipped (1584)

Patient Problems Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Complaint, Ill-Defined (2331); Disability (2371); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

I had the corin-cormet metal on metal hip resurfacing implant surgery in (b)(6) 2011.It did not work from day one.Really got sick physically and mentally.I ended up having a total ceramic and whatever, done in (b)(6) 2013.I lost everything because of the metal on metal resurfacing.My house is gone, my job (had to retire at (b)(6) went for a year before i retired with no money coming in), no insurance, lots of debt and now will be without a car, because you people will not recall that stupid implant.What do us poor people who worked hard all their lives, raise 3 children (even with a divorce), never lived on any government support, do with nothing and a lot of aches and pain and lack of some mobility.I do know there are a lot of people out there that are suffering the same because of the implant.What more can we do? i also know that there are litigations being done in (b)(6) and elsewhere on the corin-cormet metal on metal hip resurfacing implant.Does someone have to die because of the reactions and bad effects of this? like gm let it go and see what else will happen because it's too costly to recall.I received a warning letter from (b)(6), who had been notified by you people about the bad reactions and effects of this implant.I contacted my doctor right away when i received the letter in march of 2013.Took x-rays and sure as heck it had totally loosened, flaked, pop in and out and had failed, with a lot of pain with it.I lost my muscle which had atrophied, my other hip now is bad, and almost lost most of my mobility.What more do you need? no lawyers will take this because of your approval and the pma, which they did rather underhanded.I have always been independent and could pay my bill, now i can't, even with (b)(6) that i got after 2 years of failure.I believe it should be addressed, and i should be compensated for no insurance, lost wages, a lot of debt, and pain and suffering for 3 years.Please i beg of you before it's too late, look into this.I see stryker no longer uses the parts that i had.How about that.I also want you to know i have contacted my senators who are looking into this also and my governor.No one should lose everything because they trust their doctor and the government on what goes into you.Please contact me and let me know what is happening with this.I have gone through 10 or more lawyers.

• Brand Name: STRYKER METAL ON METAL RESURFACING
• Type of Device: HIP RESURFACING IMPLANT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3896137
• MDR Text Key: 4424140
• Report Number: MW5036803
• Device Sequence Number: 1
• Product Code: KXA
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 73