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. Objective: To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall. Design, Setting, and Participants: In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through December 31, 2021, giving a minimum 2-year follow-up after initial approval. Data were analyzed from July 6 to August 6, 2022. Retrospective, time-to-event analysis investigated the association between the number and type of supplements and risk of recall. Exposures: Supplements submitted by manufacturers for FDA approval to modify devices. Main Outcomes and Measures: A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for class 1 (high-risk) recall. Explanatory variables are the number of supplements, number of panel track supplements, and cardiovascular devices. Multivariable analysis was performed to identify independent risk factors for recall with hazard ratios (HRs) as the main end point. Results: A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices contributed 138 supplements (37.0%), followed by microbiology with 45 (12.1%). No other specialty contributed more than 10%. Multivariable analysis demonstrated that each increase of 1 supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < .001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = .01) and cardiovascular vsnoncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = .03) were significantly associated with an increased risk of recall. Conclusions and Relevance: The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.

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.

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. However, there are no reports on the use of calcium phosphate cement after removal of hardware in the clinical setting. The purpose of this case discussion is to present the first reported case, to our knowledge, of the use of calcium phosphate cement augmentation of the boney defect after lag screw removal, and the subsequent failure resulting in atraumatic 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. More than 97% of orthopaedic devices go through the FDA's 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive premarket approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Postmarketing surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products.

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. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

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. To the authors' knowledge, this is the first case of its kind reported in the orthopedic literature. Emphysematous osteomyelitis, a rare and dangerous entity, can be successfully managed by intramedullary antibiotic delivery in the subacute setting. [Orthopedics. 2019; 42(1):e128-e130.].

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. This case report illustrates a novel technique for fixation and stabilization for an unusual injury involving an obturator hip dislocation and an osteochondral impaction fracture of the femoral head. CASE PRESENTATION: A 30-years old African American male, involved in a motor vehicle collision, sustained an obturator dislocation of the left hip with a large posterior osteochondral fracture of the femoral head. An emergency closed reduction procedure was performed followed by a computed tomography (CT) scan of the hip joint which demonstrated a large osteochondral defect (25 x 10 mm, depth: 5 mm) of the femoral head, visualized within the weight-bearing area. Surgical intervention was planned as a fracture of the femoral head with a defect deeper than four millimeters has been shown to be a risk factor for the development of post-traumatic arthritis, often with onset of symptoms within 5 years of the date of injury. Following surgical hip dislocation, the defect of the femoral head was reconstructed with implantation of a femoral head allograft and internal fixation. At the six months follow-up, the patient could ambulate with minimal pain and without assistive devices. Radiographs demonstrated maintenance of articular congruity with no evidence of implant failure, post-traumatic arthritis or avascular necrosis. CONCLUSION: Surgical hip dislocation and reconstruction using femoral head allograft used to treat obturator hip dislocations with concomitant femoral head impaction fractures can lead to satisfactory short term functional outcomes.

Second Place Award 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. The goal of the current study was to assess the short-term complication rates in low-energy tibial plateau fractures treated early (<48 hr). As a secondary aim, we investigated whether surgical approach would affect rates of wound complications. METHODS: This is a retrospective analysis of patients treated operatively for low-energy tibial plateau fractures at a level-1 urban trauma center between January 1, 2000 and January 1, 2010. Schatzker type 1-3 fractures were considered "low-energy," despite stated mechanism. Statistical analysis was performed using chi-square and Fischer's exact tests. RESULTS: We analyzed 49 patients. From these, 29 received early (<48 hr) definitive surgery, while 20 had surgery delayed (>48 hr). The early treatment group had an infection rate of 3.4% and total complication rate of 20.6%. The delayed treatment group had an infection rate of 5.0% and total complication rate of 25%. There was no significant difference with respect to superficial infection (P=1.0), deep infection (P=0.48), or total complications (P=0.74) Additionally, infection rates did not differ between surgical approaches (P=1.0, 1.0). CONCLUSIONS: Early surgical fixation (<48 hr) of low-energy tibial plateau fractures can be performed safely. Additionally, a midline approach did not increase soft-tissue complications and could be utilized in a patient with a prior midline incision, or one who will soon require a knee arthroplasty.

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. The posterior approach has been nuanced to match needs related to fracture pattern and timing of surgery. Reducing the fragments and stabilizing them can be challenging but, a satisfactory reduction and stable fixation can be achieved, which allows immediate motion and rehabilitation.

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. This has led to a growing recognition that scapular fractures should be held to the same standards as other bodily fractures with regard to fracture fixation principles, including anatomic articular reduction, proper alignment, and stable internal fixation. Through research, there has been an improved understanding of scapular fracture patterns and the relevant surgical approaches and exposures used for fracture fixation. As with many bones, however, there still remains the absence of a compelling study that defines thresholds for surgical indication based on degrees of deformity and amounts of displacement.