As DePuy, Stryker struggle with recalls, a new testing method emerges
It’s no secret that over the past few years manufacturers of knee and hip implants have faced widespread criticism over these devices, and their propensity for early failure. In a recent lawsuit, the DePuy unit of Johnson & Johnson was forced to pay $8.3 million in compensatory damages to an individual who claimed his metal-on-metal hip implant became dislocated, causing him pain and forcing him to undergo revision surgery.
But the issue hasn’t been limited to DePuy. Stryker, for instance, recently received a warning letter from the U.S. Food and Drug Administration (FDA) over marketing practices and quality-related concerns at its facility in Portage, Michigan, Reuters reports. Stryker, a manufacturer of medical devices including hip implants, issued a recall related to these products last year, the news source said.
Similarly, Biomet UK, another medical device manufacturer, recently issued a field safety notice over an issue related to an oversized axle component of its knee implant system. According to Orthopedics Today, the issue would theoretically force surgeons to wait for a replacement part before completing the knee operation on patients.
Problems in the manufacturing process of these devices can be significantly costly for the companies marketing them to patients around the world. As a result, the need for smart, efficient testing of these products becomes enormous. Currently, Sentient is working with Zimmer, an Indiana-based medical device manufacturer, on a new predictive wear model for its hip implants. The technology, originally created for Naval use, is modeling elastomeric wear that is designed to predict application-specific performance. This focused testing allows the company to evaluate the performance of a nearly unlimited number of cases, ultimately reducing the risk of product failure.