This case involves a 79-year-old male patient who underwent a scheduled hip replacement. The surgeon had requested a size 36 implant for the patient’s procedure. The size 36 implant arrived in mislabeled packaging and had actually held a size 33 implant. Neither the surgeon nor the operating room nurse checked the size number that was engraved on the actual implant prior to commencing the surgery. As a result, the patient had an implant placed that was too small and the implant failed. The patient required a revision surgery and suffered multiple complications as a result. An expert orthopedic surgeon with a track record of performing successful hip surgeries was sought to address the standard of care with regards to confirming the size of implants after removal from the packaging and opine on how inserting an implant of incorrect size can lead to implant failure.
Question(s) For Expert Witness
1. In your experience, are the surgeon and scrub nurse required to confirm the size of the implant before placing it in the patient?
2. How might an implant that was too small lead to implant failure?
Expert Witness Response E-192100
I am very familiar with microport products and I have recently implanted them. With regard to confirming the correct implant size, the surgeon is always the last stop. However, all members of the team should work together. If there is a labeling issue on the package, there will be a large share of liability attributed to the manufacturer. This should be very clear. There is a product label on the packaging that is part of the medical record. If the patient has been revised there is a laser etching on the head confirming the size (if it's metal). If it was a ceramic head it was made by BIOLOX which makes all ceramic heads currently used in the US.
Most protocols for best practice have the representative show the packaging to the surgeon who confirms the correct size. The circulating nurse then opens the packages and also confirms the size and records it in the medical record with implant stickers. The scrub should then read out the marking on the implant and the present the final implant to the surgeon so that he/she can see the marking finally confirming the size. With a familiar team, there may be a level of trust between the surgeon and the other members so that procedure may be somewhat abbreviated. But the final responsibility will always fall on the surgeon. If an implant was labeled as one size and packaged as the wrong size, there is a significant liability to the manufacturer. We trust that a 36mm is a 36mm if it's labeled on the package and implant as a 36mm- if that's the case, it's very interesting and exceedingly rare. Stability of the hip joint is very dependent on the positioning and sizing of the joint. If there was a mismatched head/cup combo it would have no hope for success. The cup liners in total hip come in different sizes that are matched to the head. A 36mm liner matched to a 32mm head would be obvious and would not be stable intraoperatively. The post-films would also be askew.
About the author
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
