Embattled medical device manufacturer DePuy Orthopaedics has been forced to recall unused products from at least a dozen of its custom device components.
These custom components were able to be prescribed by physicians and surgeons despite not going through the customary pre-market approval processes. The Food and Drug Administration told the company via warning letter that it must seek new pre-market or 510(k) approval applications in order for it to continue selling these products. It said the products among the dozen included in the recall have never gained proper FDA clearance or have been modified in a way that requires new approval.
DePuy is the manufacturer of the highly controversial ASR and Pinnacle brand of all-metal hip implants. The devices have been responsible for thousands of injuries and in August 2010, the company was forced to remove the ASR model from the market due to its extremely high early failure rate.
According to a report at MassDevice.com, the FDA issued the warning letter to DePuy Orthopaedics, a subsidiary of Johnson & Johnson, in January but the contents of that letter were only unsealed from confidentiality last week. In response to the letter, DePuy Orthopaedics said it would halt sales, at least temporarily, on all custom medical devices it manufactures.
DePuy is now informing surgeons that it is taking this action and that they should stop using any of its custom medical devices. Any devices that have already been implanted in patients are not included in the recall. Since 1999, the report adds, DePuy has sold at least 8,300 custom medical devices that would fall under the categories listed in the recall. There is no indication exactly how many custom-made devices are included in the company’s latest action.
The leading medical device manufacturer is currently facing an increasingly large amount of legal trouble over the defects in its line of metal-on-metal hip implants and hip implant components. Thousands of recipients of its ASR metal-on-metal hip implant have already experienced catastrophic problems with the devices.
The ASR has been pegged for recall due to its high failure rate, estimated to be at 13 percent of devices within the first five years of it being implanted in a patient. Touted as being a better alternative to other hip implants, the all-metal hip implants were supposed to last longer and be an ideal alternative to younger recipients who normally weren’t candidates for hip replacement surgeries due to the likelihood of having more than one replacement surgery during their lifetime.
With the ASR, recipients found themselves on the surgeon’s table many times soon after they received the implant. A high failure rate combined with an all-metal hip implant’s tendency to disperse small metallic fragments into the body, leading to a toxic accumulation of the dangerous metals cobalt and chromium.
Tens of thousands of people received the ASR metal-on-metal hip implant and since its recall, the company has been constantly receiving notice that it is the subject of more personal injury lawsuits.
The company is accused of rushing metal-on-metal hip implants through the same approval process it does for its custom-made medical devices and that has resulted in the recall and thousands of recipients experiencing costly and painful setbacks.