DePuy Pinnacle Hip Replacement
The DePuy Pinnacle Hip Replacement System was approved for sale by the Food and Drug Administration (FDA) in 2000. It was introduced to accommodate the active lifestyle of younger hip replacement patients by providing more flexibility and range-of-motion than existing hip replacement devices. It was also supposed to eliminate the problem of device failure due to continued use.
DePuy introduced this system used for total hip replacement as having been developed in consultation with orthopedic surgeons and biomedical experts. The product line included: ceramic-on-polyethylene, metal-on-polyethylene, ceramic-on-ceramic, metal-on-metal, ceramic-on-metal.
The reason for so many options for bearing surfaces, or the surfaces where the head replacement for the thigh bone and the cup replacement for the hip socket rub together was to allow the surgeon to select according to the individual needs of the patient receiving the implant. The more durable the material these components were made from, the more they could withstand active use without prematurely failing.
Problems And Complications With The Pinnacle Hip Replacement
The Pinnacle metal-on-metal system generated the same adverse reactions in patients that are typical of all devices manufactured in this way. In a Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) report, a surgeon who had removed a Pinnacle metal-on-metal device from a patient explained that implant “had caused significant synovial inflammation and metallosis reaction”. That means that the inner layer of soft tissue that lined the sac-shaped envelope that encloses the cavity of the hip joint became inflamed, which was a reaction to the metal particles released as the implant erodes over time.
The surgeon further reported that the patient, who needed an i9mpant as a result of hip arthritis, did get relief from the medical condition after the implant. However, the device was only viable for about seven years, a much shorter length of time than the15 year average that is expected from a hip replacement.
The surgeon concluded the report with the following observation:
“The relevance is that this is a different product within the same company -depuy orthopaedics- which has recently had a different metal-on-metal hip implant recalled by the fda – the asr hip system-. This is to report a problem with their pinnacle metal-on-metal system. The common factor being the metal-on-metal bearing, leading to metal particulate release, and significant synovial reaction, and necessitating revision surgery and implant removal. Patients should be made aware of the significant risk associated with this system.”
The DePuy Pinnacle Hip Replacement And Revision Surgery
To date, the FDA has received approximately 1,300 adverse reaction reports regarding the Pinnacle device, which indicate the need for the patients involved to have revision surgery to remove the implant. While the product was marketed as having a flawless construction that permitted frictionless movement with a hip socket replacement cup that didn’t need to be cemented in place, a titanium shell, and a liner made of either polyethylene or metal-on-metal, this wasn’t the case. The metal-on-metal design does, in fact, create friction between the cup and the ball-shaped replacement head of the thigh bone causing the device to prematurely erode and release metal ions that have both short-term and possible long-term effects.
Over the short-term, the cobalt and chromium that are released could cause inflammation in the joint, which result in pain and difficulty of movement. Over the long-term, the possible adverse side effects include cobalt poisoning, which could cause cognitive and cardiac damage.
In a lawsuit filed on May 21, 2009, the patient stated that revision surgery was necessary after only one year after implantation, attesting to the high failure rate of the device, which has been another cause for many of the lawsuits filed against it.
Conflict of interest between surgeons and device manufacturers
In a special repost published in the Archives of Internal Medicine, researchers examined data from the Department of Justice settlement with five major joint replacement manufacturers, one of which was DePuy Orthopaedics, to find:
- How many orthopedic surgeons received payment to use the companies’ devices
- How large these payments were
- The total dollar amount each company paid out
- The proportion going to orthopedic surgeons affiliated with academic institutions
The researchers’ findings for the five companies, which spanned the years from 2007 to 2008, were as follows:
- In 2007, 1041 payments totaling more than $198 million were made to 939 orthopedic surgeons.
- In 2008, 568 payments totaling more than $228 million were made to 526 orthopedic surgeons.
- The number of surgeons who had academic affiliations who received payments increased from about 39 percent in 2007 to over 44percent in 2008.
Approximately 1,000 of the 25,000 orthopedic surgeons in this country received fees for consulting, royalties on products they helped develop, and payments for research and clinical study work from these five companies.
In addition, researchers also looked at 2009 and 2010 disclosures from DePuy, one of three firms who continued to release information on a voluntary basis. They found that not only did the number of payments to surgeons increase in those years, but also the proportion given to surgeons with academic affiliations rose. However, they didn’t return to 2007 levels.
DePuy Hip Replacement Lawsuits
In the first nine months of 2011, there were approximately 560 claims related to the Pinnacle hip system. The majority of these are included in a federal multidistrict litigation in the U.S. District Court for the Northern District of Texas under the supervision of District Judge James E. Kinkeade.
The claims allege that the Pinnacle system had a design defect and that neither Johnson & Johnson nor DePuy provided adequate warning about the potential side effects of using the device. While there are several different material combinations, the metal-on-metal version is the one that seems to be focus of the majority of complaints.
Sources:
- Johnson & Johnson’s Blunder – DePuy’s Pinnacle the Latest Revision Surgery Devil. (n.d.). Retrieved January 16, 2012, from http://www.scribd.com/doc/55658194/Johnson-Johnson%E2%80%99s-Blunder-%E2%80%93-DePuy%E2%80%99s-Pinnacle-the-Latest-Revision-Surgery-Devil
- Johnson & Johnson. (2011, November 8). Form 10-Q Quarterly Report. Retrieved from http://www.investor.jnj.com/secfiling.cfm?filingID=950123-11-96471
- Hockenberry, Jason M., et al. (2011). Financial Payments by Orthopedic Device Makers to Orthopedic Surgeons. Archives of Internal Medicine, 171(19)1759-1765. doi:10.1001/archinternmed.2011.454
- MAUDE Adverse Event Report. (2010, November 30). Food and Drug Administration. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1932627
- Pinnacle Hip System. (n.d.). DePuy Orthopaedics, Retrieved January 13, 2012, from http://www.depuy.com/pinnaclepatient
