The Food and Drug Administration (FDA) has been cracking down on one of the manufacturers of hip replacement implants. The FDA has recently sent Stryker Orthopaedics a six-page letter detailing the problems with the company’s manufacturing process and other issues that need to be corrected immediately. There have been several problematic reports that led to recall Stryker metal hip replacement systems. However, in answer to the FDA investigation, Stryker Orthopaedics has voluntarily recalled two brands of metal hip replacement devices. The recall affected the Rejuvenate Modular and the ABG II modular-neck hip stems because of its potential break down and corrosion that may result in tissue pain and swelling.​

Because of the growing evidences of all-metal hip replacement problems, the FDA has assembled a meeting with medical experts to discuss the safety of the metal hip implants, amid the concerns there are more side-effects than with implants made out of such materials as ceramic and plastic. Patients reported pain and swelling that requires removal of the faulty device.​

The panellist of the meeting are concerned that as the metal ball and socket wear out, some tiny metal particles may be released into the bloodstream and into the space around the implant. However, different people will react to these metal particles in different ways. At this time, it is not possible to know who will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be. Some surgeons are alarmed that over time, metal particles around the implants may cause damage to bone and/or tissues. Such reaction may cause the implant to become loose or cause pain. Ultimately, this may potentially require revision surgery where the old device is removed and replaced with a new one.​

Moreover, there were also FDA-generated reports of the presence of disease-causing germs, known as Straphylococcus bacteria, in the company’s manufacturing plant in New Jersey after an inspection of the facility. This may increase the risk of infection following the surgery.​

The Stryker company suggested that patients should have a regular check up with their doctors. Patients with Stryker Rejuvenate or ABG II hip replacements may need to see their orthopaedic surgeons if they develop any symptoms stated above for further evaluation. They may also refer to the website about Stryker Hip Recall  found on the net for more information.​


References:​

medpagetoday.com/PublicHealthPolicy/FDAGeneral/33706​

bizjournals.com/boston/news/2012/07/10/stryker-recalls-hip-replacement.html​

reuters.com/article/2010/03/23/idUS209004+23-Mar-2010+PRN20100323​

boston.com/business/healthcare/2012/06/27/fda-probes-safety-issues-with-metal-hip-implants/S5DL91jpgvDAntQqIcCtfN/story-1.html​