On July 24th, 2008, Zimmer Inc. had a recall on their prosthetic hip implant the Durom Cup. The Durom Cup has been implanted in over 12,000 patients since it was first sold in the United States in 2006.

Failure and Defect of the Zimmer Durom Hip Replacement System Cup
We are aggressively investigating and reviewing cases where patients have experienced defects and failures involving the Durom hip replacement cups manufactured by multinational joint replacement device manufacturer Zimmer, Inc.  It is believed that Zimmer marketed the Durom hip replacement cup knowing that this hip cup was defectively designed and would result in a significant failure rate. In fact, Zimmer has marketed its Durom Hip Resurfacing System as being designed for use in young, active patients who are likely to outlive a conventional hip prosthesis.

Indeed, on April 22, 2008, Dr. Larry Dorr, a world renowned orthopedic surgeon and Director of the Dorr Institute for Arthritis Research and Education, wrote the following letter to his colleagues at the American Association of Hip and Knee Surgeons warning of the failures and defects associated with Zimmer’s Durom hip cup:

This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one). These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions.

If you or someone you know has had a Durom hip cup surgically implanted and believe it has failed, was defective, needs to be removed, or has already been revised, you should have your potential defective hip case reviewed. If you do not know if your hip implant is a Durom hip manufactured by Zimmer, Inc., call your surgeon and get a copy of your hospital medical chart.

Please retain your orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, the device record for the original surgery from the hospital chart and the Durom hip resurfacing cup.

Stryker Corporation Hip Defects
On May 5, 2008, the FDA issued its third warning letter to implant manufacturer Stryker Corporation regarding serious issues with its implanted prosthetic devices. The letter, which can be found at http://www.fda.gov/foi/warning_letters/s6760c.htm, focuses on Stryker’s biotech division in Hopkinton, Massachusetts, which manufactures products which promote bone growth, used in prosthetic devices implanted without cement.   The warning discusses issues regarding the division’s handling of clinical studies, its quality system, medical device reporting procedures, and falsification of documentation approving implantation.  In other words, the FDA finds Stryker’s response to the FDA’s previous findings of numerous compliance violations, including problems with equipment used in its manufacturing inadequate.  The FDA also found that Stryker’s control processes for insuring the quality of its products, and reporting of complaints and adverse events related to its products are severely lacking and in violation of federal law.

On January 22, 2008, Stryker Corp. issued a recall of  its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cups.  Acetabular Cups are used in the socket portion of replacement hip components.  The PSL version is the most commonly used Stryker cup in the U.S.   The company’s recall involved prosthetic components which were manufactured at Stryker’s Cork, Ireland plant due to concerns of possible contamination.    The recall was issued after Stryker received two warning letters from the FDA regarding conditions at their manufacturing facilities in Ireland and Mahwah, New Jersey.   

The first FDA warning letter of March 15, 2007 discussed problems with several Stryker products, including the Duracon and Scorpio knee replacement components, the Trident Acetabular System, Restoraration Modular Revision Hip System, the Accolaade Cemented Hip System, the Accolade Femoral Hip System and the Dall-Miles Reconstruction and Trauma Cable System.  An inspection of the Ireland facility had revealed that the devices were adulterated in that the methods used in or the facilities or controls used for their manufacture, packing, storage or installation were not in comformity with the Current Good Manufacturing Practice requirements of the U.S. Code of Federal Regulations.   The letter complained of several testing problems and failure to document risk.   The letter discusses an earlier voluntary recall of  Stryker hip fracture stems, and cites several instances where the company failed to determine the cause of problems that resulted in the recall.

The second FDA warning letter, issued November 28, 2007, which can be viewed at http://www.fda.gov/foi/warning_letters/s6627c.htm specifically targeted the Mahwah, New Jersey facility, citing problems discovered during an inspection of the plant, including discovery of Staphylococcus bacteria clusters throughout the plant.   The letter warns Stryker for its failure to perform corrective actions in order to prevent the recurrence of nonconforming product or other quality problems, including failure to identify the root cause of the Staphylococcus contamination.     The letter also addresses Stryker’s failure to implement corrective procedures in response to numerous reports of adverse events with its Trident hip device, including delamination of the plasma sprayed coating on the device, poor fixation or failure to adhere to bone requiring revision surgery, improper seating of the device resulting in bone fracture, wear and fracture of the device, as well as a high incidence of squeaking noises emanating from the implant upon regular walking by the implanted patient.  

Increasing evidence of a potentially catastrophic problem with Stryker’s ceramic on ceramic hip prosthesis has also arisen recently.  A medical journal article published recently in the Journal of Arthroplasty reported a high incidence of Stryker’s Trident Hip Implant recipients experiencing squeaking, popping and other noises during simple walking, which are not only highly annoying, but also raise concerns about the possibility of future shattering of the ceramic component, which could send numerous inflammatory shards into a patient’s tissues, causing extreme consequences.

If you or someone you know has had a Stryker prosthetic device surgically implanted and believe it has failed, was defective, needs to be removed, or has already been revised, you should have your potential case reviewed. If you do not know the manufacturer of your implant, call your surgeon and get a copy of your hospital medical chart.

Please retain your orthopedic surgeon's office chart, the operative reports for the original joint replacement surgery and the revision surgery, the device record for the original surgery from the hospital chart and insist that your surgeon retain the removed prosthetic device after revision surgery and deliver to you to preserve as evidence.

Consult A Doctor On Medical Issue
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. Patients should talk to their physicians to decide whether they are at risk with their hip implant.

Consult A Lawyer on Legal Issues
If you or a loved one have suffered an injury due to a defective hip implant from either Zimmer Inc. or Stryker Corporation, call or e-mail for a free consultation.

Please e-mail Andrew E. Steinberg* at:  andrewsteinberg@lawyer.com for a free, confidential consultation, or call us at 888-529-4688.

Our description of your legal rights is not intended to imply that any product is defective. That can only be determined through a case-specific investigation.

Zimmer is a registered trademark of Zimmer, Inc.. The use of this trademark is solely for product identification and informational purposes. Zimmer, Inc. or any of its companies are not affiliated with this website.

Stryker is a registered trademark of Stryker Corporation. Stryker's product names are either trademarks or registered trademarks of Stryker. Other product and company names mentioned herein may be trademarks or trade names of their respective owners.

*Not Certified by the Texas Board of Legal Specialization.