Risk of Recall for Total Joint Arthroplasty Devices Over 10 Years.

BACKGROUND: Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are approved without supporting clinical data through the Food and Drug Administration's 510(k) pathway. The risk of recall of orthopaedic arthroplasty devices approved through the 510(k) pathway has not been previously studied. METHODS: The FDA 510(k) database was queried for orthopaedic devices approved between January 01, 2008 and December 31, 2018 and subsequently codified to hip and knee arthroplasty devices using product codes. The database included 904 arthroplasty devices during the study period, with hip and knee making up 53.7% (485) and 46.3% (419) of devices, respectively. Information regarding numbers, dates, and reasons for recall were recorded. Cumulative incidence function was conducted to compare the risk of recall between hip and knee arthroplasty. RESULTS: In total, 94 (19.4%) hip and 85 (20.3%) knee devices were recalled. The hazard of recall by 10 years for hip and knee arthroplasty devices was approximately 24%, with no statistical differences between each region. The most common causes of recall were process control and device design, accounting for 29.6% and 26.3% of recalls, respectively, with no significant difference between study groups. CONCLUSION: The risk of recall for arthroplasty devices is more than that previously understood. Improved postmarket surveillance strategies along with increased physician participation in detecting and reporting device safety issues are necessary to strengthen patient safety.

Epidural Steroid Injections.

Epidural steroid injections (ESI) can be an effective treatment of radicular pain, while also providing potential for functional improvement. There are 3 main interventional approaches including: interlaminar (IL), transforaminal (TF), and caudal. The risks and efficacy data vary between these routes of injection and the underlying pathology with the TF route having the most robust efficacy data. However, selecting an injection approach should be based on a patient's clinical presentation, pathology, anatomy, consideration of the natural course of pain, and the unique risks and benefits of the particular technique.

Methamphetamine Intoxication and Perioperative Complications Following Orthopaedic Surgical Procedures.

Background Methamphetamine use is increasing in prevalence. There is a theoretical increased risk of complication postoperative due to catecholamine depletion. When presented with an urgent surgical problem, there are little data to help counsel the patient on the risks of undergoing surgery in the setting of a positive methamphetamine test result. Aims and objectives The aim of this study was to examine the perioperative complication rate for patients who underwent emergent orthopaedic procedures in the setting of a positive methamphetamine drug screen. Additional data were collected in an attempt to further stratify risk factors for perioperative complications in this patient population. Design and methods A retrospective case series of 110 patients. Patients were identified by querying the medical record for patients with a positive methamphetamine result within 24 hours of the surgery start time. Data were collected on each patient, including the nature of the surgery, the type of injury sustained, disposition from the operating room, among other data points. The primary outcome was the presence of a perioperative cardiopulmonary complication, as determined by a new diagnosis made in the chart. The secondary outcome was whether the patient needed an increased level of care postoperatively. Results Of the 110 charts reviewed, three patients sustained complications during their hospitalization; an overall complication rate of 2.7%. One patient developed acute respiratory distress syndrome (ARDS), while two others developed surgical site infections. Of the 19 patients who went to the intensive care unit (ICU) postoperatively, none were because the patient required a higher level of care than the preoperative level. Conclusions Patients who underwent emergent surgical intervention in the setting of a positive methamphetamine drug test had a low complication rate. While the dogma is to delay surgery in the setting of methamphetamine use, the true risk of undergoing surgery in this setting is not fully understood. We advocate for continued research in this poorly studied group of patients. Larger studies will need to be done in order to fully understand the risks associated with operating in the setting of a positive methamphetamine drug screen.