Synovo SARL

The FDA said it became aware of the implant’s hardware modifications in 2022, and issued Synovo a warning letter in March 2023. The FDA is urging healthcare providers to stop purchasing and implanting a total hip replacement system sold by Synovo and recommended that orthopedic surgeons remove all components from their inventories. In its notice, the agency said that parts of the implant have been “significantly modified” in the 30-odd years since it went through federal review and first received a regulatory clearance in 1991.  The FDA is also providing care guidance for patients who may have had a procedure employing the company’s femoral resurfacing cup, acetabular fixation cup or acetabular bearings since 2019—some of which are sold as stand-alone products. The total hip system has also been referred to as the Synovo Preserve and the Endotec BP, the agency said. The FDA said it became aware of the implant’s hardware modifications in 2022, and issued Synovo a warning letter in March 2023.  At that time, inspectors pointed to changes in the company’s femoral resurfacing cup, which had originally been cleared with a caveat that it could not be promoted for use without bone cement. However, they said they found instructions directing users that the implant now had a coating allowing it to be used in cementless fixation. “The referenced changes, individually and collectively, are likely to expose patients to increased risks of loosening and subsequent revision surgery (e.g., from pain, proximal femur fracture, or component fracture),” the warning letter said.  The letter also said the California-based company had been marketing some of the system’s components without first obtaining premarket approval, and it directed the company to halt manufacturing immediately. “Based on currently available information, the FDA does not recommend [surgical] removal of Synovo Total Hip Systems from patients who do not have any new or worsening pain or symptoms,” the agency said in its January 3 notice. The FDA said that patients should be closely monitored, including through X-rays, for potential bone loss, implant loosening or suspected device failure. Patients should also contact their providers if they have new or worsening pain, grinding or other noise, or weakness of the hip or knee on the side of the implant.

Synovo has modified three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, from the devices initially cleared by the health agency FDA advises against use of certain hip implants from Synovo. (Credit: Alan Calvert on Unsplash) The US Food and Drug Administration (FDA) has provided recommendations for healthcare providers who consider using the Total Hip System, including resurfacing implants, made by Synovo Production. The Synovo Total Hip System is designed for patients receiving a total hip replacement, commonly known as total hip arthroplasty. The FDA has also issued recommendations for patients who received certain implants used in the system after 2019. Synovo has modified three components of the system, the Femoral Resurfacing Cup, the Acetabular Fixation Cup, and the Acetabular Bearing, from the devices initially cleared by the health agency. According to US FDA, the effectiveness and safety of the system and its three components have not been established. The Total Hip System is also known as the Total Hip Replacement System, and also as Synovo Preserve and Endotec BP. The FDA was informed in 2022 that the three components have undergone major changes. Following an inspection, the agency sent Synovo a warning letter. Synovo was directed to stop producing the modified devices immediately and take immediate corrective action for the violations mentioned in the warning letter. The American health regulator has asked that the business inform its customers of the risks connected to the modified devices. The FDA and Synovo will keep collaborating to bring the devices into compliance with its regulations. For affected patients, the agency has advised them to contact their healthcare provider if they feel new or worsening pain, inability to bear weight or weakness of the hip or knee on the side of their implant. Furthermore, the FDA doesn’t recommend surgery for those whose implant functions well and experience no pain or deteriorating symptoms. The US FDA suggested that healthcare providers not buy or implant the existing Synovo Total Hip System and remove the modified components from the inventory. Additionally, the health regulator suggested them to closely monitor patients who received the Synovo Total Hip System for possible bone loss or device loosening, wear, or failure.

Japan is setting up ID card readers with face recognition authentication provided by US-based computer vision platform SAFR. Developed by system integrator Nextware, the My Number Card Reader will provide online authentication of a Japanese resident's 12-digit social security and taxation ID number called My Number. It reads the user's photo information stored on the IC chip in the ID card and can even verify the cardholder using facial recognition even if they are wearing a mask. SAFR's algorithm has been chosen and integrated into the reader for its "speed, precision and extremely low bias with regard to skin tones, age, and gender," the company said in a statement. WHY IT MATTERS The card reader scheme, according to SAFR, is envisioned to "significantly reduce resources and costs associated with the administration of healthcare information while increasing convenience and access for all citizens and residents". THE LARGER CONTEXT The use of the My Number cards to access government healthcare services in Japan began in October. This comes in part of the government's digital transformation to streamline and expand access to public services. The Japanese government intends to widen the uptake of the My Number cards so citizens will no longer have to use multiple cards to tap into government services. As it stands, medical institutions and pharmacies accepting these cards for health insurance account for about 8% of all facilities nationwide, a news report noted. The card reader system is being rolled out across hospitals, clinics and pharmacies over the next two to three years.