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BACKGROUND Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. METHODS The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. RESULTS In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. CONCLUSION Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).

Category: Midfoot/Forefoot Introduction/Purpose: The superiority of Primary arthrodesis (PA) versus open reduction and internal fixation (ORIF) in Lisfranc injuries has been debated for decades. In recent years, researchers have attempted to use meta-analyses to reach a definitive conclusion. However, they have reached uncertain and contradicting conclusions when comparing these treatment options, which has led to more confusion. The goal of this paper is to navigate the primary source data of each meta-analyses to determine why different conclusions were reached and provide surgeons with more clarity on the comparable outcomes of PA and ORIF treatment options in Lisfranc injuries. Methods: A systematic literature review was conducted by searching for ‘meta-analysis’ AND ‘Lisfranc’ with keywords such as ‘ORIF’ OR ‘open reduction’ OR ‘Arthrodesis’ OR ‘fusion’. Five meta-analysis articles discussing PA and ORIF in Lisfranc injuries were identified. Study outcomes were extracted from each article for comparison. Contradicting conclusions were identified, and the primary sources used by each meta-analysis was analyzed. Results: All meta-analyses agreed that PA had lower rates of hardware removal and that there is no significant difference between PA and ORIF when considering revision surgery, anatomic reduction, postoperative infection, total complications, and patient satisfaction. However, contradicting conclusions were reached regarding functional patient outcomes such as return to duty, the American Orthopaedic Foot & Ankle Society (AOFAS) score, and visual analogue scale (VAS) score. Conclusion: PA has favorable rates of hardware removal compared to ORIF, while no difference between PA and ORIF was found for revision surgery, anatomic reduction, postoperative infection, total complications, and patient satisfaction.While certain meta-analyses had contradicting conclusion as to which treatment option is favorable for returning to duty, AOFAS score, and VAS score, it was determined there was no significant difference in PA and ORIF for return to work and VAS score. Repeat meta- analysis with truly equivocal outcomes would be necessary to reach a valid conclusion for return to full activity and AOFAS midfoot scores.

Background This study evaluates the safety of foot and ankle outpatient surgeries at a freestanding ambulatory surgery centers. Methods A total of 1352 cases were evaluated for adverse events in a retrospective review of all foot and ankle cases performed over a 5-year period at a single center. Results The rate of adverse events was 2.3%, with 31 identified over the 5-year period (23 infections, 5 symptomatic thromboembolisms, 3 postoperative hospital transfers). Discussion The rate of postoperative adverse events in outpatient foot and ankle procedures is low. These surgeries can be performed safely in an outpatient setting at an ASC. Level of evidence Level IV, Case Series.