Internal Memos Focus Spotlight on Hip Implant’s Design Flaw
How does a medical device company talk internally about design flaws discovered in a hip implant it is promoting to thousands of surgeons?
“We will ultimately need a cup redesign, but the short-term action is manage perceptions.”
That’s what one sales official of DePuy, the Johnson & Johnson unit that makes hip implants, wrote in an email to a colleague in 2008, about its ASR hip device.
The “cup” this official referred to is the acetabular or socket component of the metal-on-metal ball-and-socket hip replacement.
And in a report the previous year about engineering tests on the ASR hip, the company’s officials wrote:
“The current results for A.S.R. do not meet the set acceptance criteria for this test.”
That was a reference to excessive wearing of the device, which was thought to lead to the high rate of failures of the ASR implant.
The upshot is that thousands of patients continued to get the defective device placed in their bodies before DePuy finally admitted the design defect and recalled the device in 2010.
Meantime, it was “managing perceptions.”
The newly revealed internal documents were disclosed in a product liability trial of the first lawsuit against DePuy to reach the courtroom. Barry Meier of the New York Times wrote the report quoting the DePuy documents.