• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number REF 1217-22-056
Event Date 12/22/2008
Event Type  Injury  
Event Description

Upfront, here are serial numbers of the cup and bone screws of my depuy pinnacle - metal on metal - ace tabular cup full hip replacement: depuy pinnacle ace tabular cup ref 1217-22-056 lot c31ef1000 sz mm 56. Depuy pinnacle cancellous bone screw - 2 screws same serial numbers (b)(4); lot af 2e6400 dia mm 6. 5 mm lgt 30. My right hip was replaced using one of the depuy devices (b)(6) 2008. For the first 3 months after surgery i was unable to lie down straight in bed, only changing certain positions hourly sitting in a recliner allowed me to bear severe and violent pain. Actually, to the day - almost 2 years after surgery, i am not able to sit, stand, or lie down for more than a couple of hours, rather less. Even when i don't move at all, severe and violent pain kicks in. During that time i also was ordered physical therapy. At the time my physical therapist also wondered why i still was in so much pain. Once i was ordered to walk on full weight, i was never able to walk more than half a mile without severe pain kicking in. Actually, to the day my hip replaced leg starts hurting badly when i walk only very short distances, much shorter than half a mile and often when i don't walk also. My surgeon always suggested to be patient as recovery from a severe operation like that could take up to a year, or more. The last time i saw my surgeon was in (b)(6) 2010. Again, i told him how severe my pains still were. Dr (b)(6) discussed a bone marrow transplant with me. A procedure that could help to fasten the stem part of my implanted hip. But dr (b)(6) recommended to stay away from that procedure as he knew of only a couple of cases, and they weren't successful. On top of it i could be on crutches for another 10 to 12 months. During this past spring/summer, i tried to see my surgeon again. Mainly because i was suffering more and more. Unfortunately, due to my long term, leave of absence i had lost my job and all my benefits including health insurance. My surgeon's front office told me over the phone that i would have to pay a fee (b)(6) just to see the doctor as an uninsured person. I simply could not afford that at the time. After i learned that i have a ace tabular cup hip replacement made by depuy orthopedics, i went to the venice regional hospital in order to request my medical records and implant report. It was a kind of odd that the clerks at the hospital said that they can provide my medical records, but that it seemed strange that they were unable to find the serial number of my depuy hip replacement. They told me that they would send me a copy when they would find it. After approx 2 weeks i received a copy of the implanted system, and it states, depuy pinnacle ace tabular. While this device is not under the official recall, it is also a metal on metal, and many articles/blog posts by doctors, lawyers and pts talk about the same symptoms i suffer from. Supposedly, the fda has more than 300 pt complaints on that device. My medical condition, personal situation and circumstances get worse and worse. Furthermore, and after my employer (b)(6) cable had terminated me because of extended leave of absence due to illness, i applied for unemployment benefits. Unemployment was denied because the agency was not able to help me because of my illnesses. Since surgery and after i started to sit for extended time, not only severe pain bothered me, also a condition called edema -excessive swelling of my right foot. Both my doctors back then - until (b)(6) 2009, dr (b)(6) and dr (b)(6) knew about that additional condition. Meanwhile i have developed more severe pain in the hip area of my operated hip, also of my left hip, back, and all the way up to the neck. My severe and violent pain is causing me a lot of discomfort, my overall medical condition seems to get worse and worse, ie. I cannot get in and outside of a vehicle without terrible pain in my right leg and right hip. I cannot get up from sitting or laying down positions without terrible pain in my left and right leg and left and right hip. I can only walk very short distances without severe pain starting inside my right leg and right hip. I move and walk very slowly, because i am afraid to fall with every single step i do. I have to sit down in order to get dressed. When i turn my neck to the left or to the right a little faster than very slow, i see 'stars'. Also, when i move my neck, another violent pain stretches out all the way down to my lower back. Both my hands and arms developed a tingling sensation that stretches all the way from the tip of my pinky fingers to the elbows. Each time i have to cough or sneeze, i experience a violent pain sensation inside right thigh and hip areas. I have diarrhea almost all the time, no matter what i drink or eat. Many times there is also blood in my stool. At the end of (b)(6) 2010, i applied for social security disability benefits. My initial claim was denied (b)(6) 2010. I am in the procedure to appeal that decision and report to the (b)(6) that i am suffering from the depuy hip replacement. I am also in the procedure to seek legal help on the matter of my failing depuy hip replacement. At the present time, i believe that i am in urgent need of medical care. Having lost medical insurance due to the loss of my job, and being denied help from the local senior citizen help center, i am trying to gain eligibility for the county's health department. While i have no complaints about dr (b)(6) care and the care i received at the (b)(6) hospital, i have a problem to see dr (b)(6) again. Reason why: i cannot afford their fees as an uninsured person. When you look up depuy orthopedics official website, and search for associated doctors in (b)(6), dr (b)(6) pops up first. Dr (b)(6) and dr (b)(6) both work for (b)(6) medical center, (b)(6). As stated above, i seek legal advice on the matter. Please, let me know if you are interested to represent me in that matter. Dates of use: (b)(6) 2008 - (b)(6) 2010. Diagnosis or reason for use: hip replacement.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
warsaw IN
MDR Report Key1932681
Report NumberMW5018613
Device Sequence Number1
Product CodeKWA
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/14/2010
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received12/14/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberREF 1217-22-056
Device LOT NumberC31EF1000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 12/14/2010 Patient Sequence Number: 1