Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.

Importance: High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed.

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.

Use of calcium phosphate cement after removal of a cephalomedullary nail: A case report.

Femoral neck fracture in the absence of trauma is a rare, but known complication after hardware removal. This complication may be due to the boney defect created by the hardware removal itself, or the increase in femoral neck strain that occurs after removal of the hardware. Previous biomechanical studies have suggested that filling the defect with calcium phosphate cement after removal of hardware may prevent the development of a femoral neck fracture.

The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.

Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product.

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance.

Intramedullary Antibiotic Delivery for Emphysematous Osteomyelitis of the Femur.

The authors present a case of bilateral femoral emphysematous osteomyelitis caused by Escherichia coli in a 60-year-old woman with rheumatoid arthritis who was receiving long-term prednisone therapy. The infection in both femoral shafts was eradicated with surgical debridement, followed by insertion of intramedullary rods composed of culture-specific antibiotic cement into the femoral canals in conjunction with 6 weeks of intravenous antibiotics. The rods were subsequently removed, and no signs of further osteomyelitis were recognized at follow-up.

Immediate versus delayed operative treatment of low-energy tibial plateau fractures.

Background: Current management of tibial plateau fractures requires careful soft-tissue management. Often a staged approach with temporary external fixation followed by delayed internal fixation is recommended. While proven in high-energy injuries, its relevance in treating low-energy fractures has not been investigated.

Novel Technique for Femoral Head Reconstruction using Allograft following Obturator Hip Dislocation.

Introduction: Obturator hip dislocations with an associated osteochondral fracture of the femoral head are uncommon. The treatment of these injuries is challenging and the functional outcomes are poor. Though the injury pattern has been described previously in literature, there are few published reports regarding treatment options.

Operative techniques in the management of scapular fractures.

Operative fixation of the scapula is associated with good outcomes. Techniques have been developed to facilitate surgical exposure of the osseous anatomy so that stability can be achieved. Although the familiar deltopectoral approach can be used for anterior glenoid fractures, the more common exposure is a posterior approach for fractures involving the neck and body of the scapula.

Scapula fractures.

Over the past decade, there has been an increased interest in understanding the operative indications and techniques in treating scapular fractures and tracking their outcomes. Multiple studies have documented poor functional outcomes following nonoperative management of displaced scapular fractures. There is a groundswell of recognition that severe deformity from scapular malunion is associated with functional consequences for patients.