MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+0; IMPLANT

Catalog Number 6260-9-140

Device Problems Nonstandard Device (1420); Metal Shedding Debris (1804)

Patient Problems Apnea (1720); Arthritis (1723); Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fatigue (1849); Pain (1994); Tissue Damage (2104); Toxicity (2333); Ambulation Difficulties (2544); Test Result (2695)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Maude report (mw5038434) was received by stryker orthopaedics and reviewed for the events the patient described.My name is dr.(b)(6) during my formative years i always kept up my physical conditioning as i was a very proactive participant in sports and exercising.In other words, i was a very healthy young man who took good care of his physical well being.After serving a term in the (b)(6) i started my professional dental practice in (b)(6).Everything went well for many years until a physical ailment forced me to have a hip implant in my left leg.The surgery went well and the recovery was uneventful.Then about one and a half years later i gradually started to lose my balance.As time went on i became more and more unsteady on my feet.I struggled with this condition for a couple of years.Soon, other things started to occur.I began getting very painful open lesions on my legs and thorax.My lungs began to deteriorate badly, and i was getting reoccurring bouts of pneumonia that would have me in the hospital for days at a time.Also my epiglottis was failing to close properly and allowing food and liquid to get into my lungs.These conditions eventually led to a long bout in the hospital where after almost dying (i ceased breathing for three to four minutes and was revived), i had to have both a permanent feeding tube put in as well as a permanent tracheostomy.Now i must spend hours each day suctioning liquids out of my lungs using special medical equipment i have at my home.Moreover, i have breathing machines i use at night when i sleep as well as a slew of expensive medicines i must take daily.Sadly, i have a special liquid nourishment that i take through my feeding tube in place of regular food now.During the time all this was going on we didn't associate any of these ailments with the hip implant.Recently, it came to our attention that the hip implant i had in my leg was defective , and i had to have it removed and a new one inserted.We soon discovered after further investigation, however, that the type of implant that was put in me originally was known to be defective all along.The implant was made in part from cobalt metal, and it was made in such a way that the cobalt from the implant was gradually poisoning my body and in fact was the cause of all of the above listed ailments in addition to others.The stryker company never once attempted to contact me to inform me of the potential side effects from its faulty implant.As it turns out they have had to recall several previous versions of their hip implant devices altogether and have been hit with a large number of lawsuits for situations like mine that have involved their previously recalled devices and the model that was put into me.By the time my implant was removed my cobalt levels were at an insanely high level of 12.7 (anything at 4.0 or higher is considered dangerous), and a lot of permanent damage had been done to my body that i will never recover from.Stryker knew about these faulty implants and their potential for danger years before my hip replacement, and yet they never bothered to warn me.If i would have been informed about this earlier we could have removed the device long before so much damage was done.Recently, i have started to wake up in the middle of the night with severe arthritis.No one on either side of my family had ever had arthritis.It gets worse almost daily and is yet another permanent ailment that i must now live with.This too is a result of the cobalt poisoning i suffered.My primary care doctor has been following my condition for many years now.He has investigated my situation thoroughly, running many tests and making many analysis over the years.He is 100 percent positive that everything i have suffered these last years (especially the feeding tube and tracheostomy, the lung deterioration, the loss of balance, the loss of energy, the painful skin lesions and the arthritis) is a direct result of the cobalt poisoning i suffered due to the malfunctioning hip implant.A strong point to make here is that my cobalt levels right befbefore surgery were measured at 12.7.Six months after the faulty implant was removed they have dropped down to just under 1.0.The cobalt poisoning that i have suffered as a result of the malfunctioning stryker hip implant has been nothing short of devastating.The fact that it was allowed to become far worse due to their failure to inform the recipients of these devices long after they knew about these potential problems makes it even worse.It has ruined my career and my life, and who knows how many others (from what i've read there are countless victims of these implants).Furthermore, stryker refuses to admit any guilt or liability whatsoever, and having been financially ruined because of my injuries i certainly cannot afford to hire any lawyers to fight on my behalf.If the fda fails to investigate and recall these defective products and can't even at least make sure the device recipients are warned and urged to get tested, then are they not as guilty of negligence as the stryker hip implant company?.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Disposition unknown.

Manufacturer Narrative

The event reported in this mdr is a duplicate of mfr report#: 0002249697-2015-00289.Any additional information will be submitted as a follow up in that report.

Event Description

Maude report (mw5038434) was received by stryker orthopaedics and reviewed for the events the patient described.My name is dr.(b)(6).During my formative years i always kept up my physical conditioning as i was a very proactive participant in sports and exercising.In other words, i was a very healthy young man who took good care of his physical well being.After (b)(6) i started my professional dental practice in(b)(4).Everything went well for many years until a physical ailment forced me to have a hip implant in my left leg.The surgery went well and the recovery was uneventful.Then about one and a half years later i gradually started to lose my balance.As time went on i became more and more unsteady on my feet.I struggled with this condition for a couple of years.Soon, other things started to occur.I began getting very painful open lesions on my legs and thorax.My lungs began to deteriorate badly, and i was getting reoccurring bouts of pneumonia that would have me in the hospital for days at a time.Also my epiglottis was failing to close properly and allowing food and liquid to get into my lungs.These conditions eventually led to a long bout in the hospital where after almost dying (i ceased breathing for three to four minutes and was revived), i had to have both a permanent feeding tube put in as well as a permanent tracheostomy.Now i must spend hours each day suctioning liquids out of my lungs using special medical equipment i have at my home.Moreover, i have breathing machines i use at night when i sleep as well as a slew of expensive medicines i must take daily.Sadly, i have a special liquid nourishment that i take through my feeding tube in place of regular food now.During the time all this was going on we didn't associate any of these ailments with the hip implant.Recently, it came to our attention that the hip implant i had in my leg was defective , and i had to have it removed and a new one inserted.We soon discovered after further investigation, however, that the type of implant that was put in me originally was known to be defective all along.The implant was made in part from cobalt metal, and it was made in such a way that the cobalt from the implant was gradually poisoning my body and in fact was the cause of all of the above listed ailments in addition to others.The stryker company never once attempted to contact me to inform me of the potential side effects from its faulty implant.As it turns out they have had to recall several previous versions of their hip implant devices altogether and have been hit with a large number of lawsuits for situations like mine that have involved their previously recalled devices and the model that was put into me.By the time my implant was removed my cobalt levels were at an insanely high level of 12.7 (anything at 4.0 or higher is considered dangerous), and a lot of permanent damage had been done to my body that i will never recover from.Stryker knew about these faulty implants and their potential for danger years before my hip replacement, and yet they never bothered to warn me.If i would have been informed about this earlier we could have removed the device long before so much damage was done.Recently, i have started to wake up in the middle of the night with severe arthritis.No one on either side of my family had ever had arthritis.It gets worse almost daily and is yet another permanent ailment that i must now live with.This too is a result of the cobalt poisoning i suffered.My primary care doctor has been following my condition for many years now.He has investigated my situation thoroughly, running many tests and making many analysis over the years.He is 100 percent positive that everything i have suffered these last years (especially the feeding tube and tracheostomy, the lung deterioration, the loss of balance, the loss of energy, the painful skin lesions and the arthritis) is a direct result of the cobalt poisoning i suffered due to the malfunctioning hip implant.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4586362
• MDR Text Key: 5337453
• Report Number: 0002249697-2015-00682
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6260-9-140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention