AAOS Now

Published 4/1/2019
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Daniel R. Schlatterer, DO, MS; Richard Schlueter, JD

Best Practices Help with Managing Failed Implants

Editor’s note: This concludes a two-part series on failed or recalled implants. The first article appeared in the February issue of AAOS Now

The first article in this series explored several of the potential liability aspects of failed implants. Although an implant failure in a patient is not malpractice per se, the duty for patient safety continues before, during, and after plaintiff attorneys advertise class action suits. This article focuses on reporting an implant problem, patient monitoring, and what to do if an implant has been recalled.

What to do if an implant has failed

Ideally, the patient should learn about the failed implant during a scheduled office visit, not from a competing office. We recommend that office staff be in the room during all discussions about the implant failure. Always assume that you are being audio- or video-recorded. Therefore, be polite, professional, and patient. Document the pertinent details of the patient visit, especially the care plan and who was present. The implant representative should know who to contact within the company.

If you do not contact the patient, who will? The manufacturer will claim that it has no patient information; the hospital will claim it does not have the fiduciary relationship. What are your options when you do not know which products were used in which patients? The manufacturer is charged with the duty and responsibility to track its product and to know that you, as the customer, have implanted the product, even if it does not have patient information. In most circumstances, a practitioner is not brought into a product liability lawsuit when there is an adequate remedy against the manufacturer and it is deemed that the practitioner will be a patient advocate in the legal proceeding. Our advice is to attempt to notify the patient, and document your actions. The impact on your time can be compensated.

What to do if an implant has been recalled

When an implant is recalled, should the surgeon perform revision surgery? The answer is yes; however, failure to appreciate potential intraoperative complications could be argued as negligence. Regarding continuity of patient care, AAOS has issued the following position statements:

  • It is not ethical for an orthopaedic surgeon to sever his or her relationship with a patient because of failure of a treatment or because no further operative treatment is indicated. The orthopaedic surgeon is ethically obligated to assist the patient in transferring care to a specialist appropriate to treat the problem.
  • The orthopaedic surgeon should practice only within the scope of his or her personal education, training, and experience. If an orthopaedic surgeon contracts to provide comprehensive musculoskeletal care, then he or she has the obligation to ensure that appropriate care is provided in areas outside his or her personal expertise.

Each physician has a professional duty to the patients in his or her practice.

Patient monitoring

Our advice is to follow up until the implant in question has been revised and the patient has met all clinical milestones of the new implant. Because it often takes months or longer for a pending implant failure to be clinically evident, frequent visits are suggested. Currently, no entity has issued surveillance guidelines for arthroplasty implants with known issues. Recommendations for laboratory tests such as serum ion levels or metal subtraction MRIs also have not been published by any governing body.

Preserving retrieved implants

Daniel Schlatterer, DO, has had experiences whereby a sterile container void of preservative liquid was delivered to the operating room (OR) head nurse in advance of explantation. The container was brought into the OR, then the device was explanted and placed in the container, which then was filled with formaldehyde. Occasionally, pictures were taken.

Operative dictation practices

The revision operative report and the explant are pieces of evidence; as such, the handling process should be tightly controlled. An explant should be sent to a certified repository; it should not be sent to the pathology department. The revising surgeon is the best person to describe the surgical findings, not the hospital pathologist. Fluid volume, color, and particulate matter in the implant locale are relevant. Likewise, local muscle decay or wasting should be documented. It is also important to dictate any cracking or wearing through of polyethylene components and corrosion signs. Describe the cement mantle and the ease with which the implant was removed, including debonding if only in certain regions. Use of augmentation for bony defects depicts a clearer picture of the consequences of a failed implant. The operative note should include the need for any future surgeries to restore functions of daily living, as well as any revisions anticipated later in life for a younger patient.

What do I do if I have been contacted by an attorney?

In most device lawsuits, the manufacturer is being sued. Make no attempt to alter or amend any of the medical documents. As the treating surgeon, you may be able to help the patient recover financial damages.

What is my exposure by testifying or being deposed?

Occasionally, an expert inspects the explant or other evidence. Damaging, tampering with, or losing an item could lead to legal ramifications. Otherwise, truthful and unbiased testimony will not result in medical liability.

What are reasonable fees?

The expert witness or treating physician will be paid for his or her time, not testimony. Hourly fees are based upon years in practice, academic achievements, and other tangibles. Fees generally range from $200 per hour for a recently board-certified surgeon to $500 per hour for a surgeon with 10 or more years of experience.

Getting revision surgery approved by insurers

The precertification process for the revision procedure is no more arduous than a primary procedure. Always dictate whether the revision is a multistage process. In a recent hip implant recall, the manufacturer covered all revision expenses.

The orthopaedic surgeon’s duty to his or her surgical patients continues indefinitely. This encompasses reporting implant problems to the manufacturer in a timely manner, preserving retrieved implants, and dictating operative notes suitable for legal proceedings.

Failed or recalled implants: Key points for orthopaedic surgeons
1. Informing patients—be proactive. Attempt to notify the patient, and document your actions.

  • The manufacturer will claim it has no patient information.
  • The hospital will claim it does not have the fiduciary relationship.

2. Product liability

  • Often, a decision is made not to bring the practitioner into a product liability suit if there is an adequate remedy against the manufacturer and it is deemed that the practitioner will be helpful as a patient advocate in the legal proceeding.
  • Therefore, be a patient advocate, and invoice for your time.

3. Patient monitoring

  • Follow up until the implant in question has been revised and the patient has met all clinical milestones of the new implant. Monitoring never ends for surgical patients.

4. Explantation and revisions

  • The revision operative report and explant are pieces of evidence. Your documentation should be descriptive and thorough.

5. Testifying

  • Expert witnesses or treating physicians get paid for their time, not their testimony.
  • Never attempt to alter or amend any of the medical documentation.

Daniel Schlatterer, DO, is a member of the AAOS Medical Liability Committee and vice chair of the orthopaedic residency program at WellStar Atlanta Medical Center.

Richard Schlueter, JD, is a partner at Childers, Schlueter & Smith LLC in Atlanta. He can be reached at rschlueter@cssfirm.com.

References:

  1. Huiskes R: Failed innovation in total hip replacement: diagnosis and proposals for a cure. Acta Orthop Scand 1993;64:699-716.
  2. Hoskin HLD, Furie E, Collins W, et al: Mechanics and complications of reverse shoulder arthroplasty: morse taper failure analysis and prospective rectification. J Phys Conf Ser 2017; 843:012019.
  3. AAOS: Code of Medical Ethics and Professionalism for Orthopaedic Surgeons. Available at: https://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/ethics/Code%20of%20Ethics%202013%20color%20logo.pdf. Accessed January 15, 2019.