Anyone who has followed the news, and you almost could not have missed it regarding the lawsuits and recalls should not see this as any kind of surprise. Back in 2011 the company received approval for a ceramic on metal device which one might guess was to replace the metal on metal.
DePuy Orthopedics Gets FDA Approval For Ceramic-on-Metal Hip Implant Pinnacle CoMplete System–Is This A Potential Replacement for the Other Ones Out There?
One company, Biomet bought a portion of the DePuy business and this was to help with the acquisition of Synthes.
Biomet Makes Offer to Buy DePuy Business from Johnson and Johnson To Enable Regulatory Clearance for The Purchase of Synthes
The FDA is also requesting study information from those manufacturers who had devices approved without full clinical studies and Johnson and Johnson said they would not be a participant as they were leaving this market. This was probably a good move as it would appear their market has probably all but disappeared for the particular ASR metal product. BD
The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industry wide trend to abandon the once widely used implants because of high early failure rates.
Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission
In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.
0 comments :
Post a Comment