FDA Logging More DePuy Pinnacle Hip Implant ComplaintsOct 7, 2011 | Parker Waichman LLP
Complaints to the U.S. Food & Drug Administration (FDA) involving DePuy Pinnacle Hip Implants with metal liners have spiked in recent months. A recent review of the FDA's Adverse Event Reports (AERS) Database found that:
- In the past three months (July-September), 709 Pinnacle Hip Implant AERs were made. Of these, 201 involved implants with metal liners.
- So far in 2011, the FDA has received 1,266 AERS involving the DePuy Hip Implant, 450 of which were confirmed to be the version with a metal liner.
- If this trend continues, the FDA could receive 1,700 Pinnacle AERs this year. It could be expect that more than 600 of those will be confirmed to involve the metal liner version.
There have definitely been more DePuy Pinnacle Implant complaints to the FDA this year than in the past. In all of 2010, the DePuy Pinnacle Hip Implant was named in 557 Pinnacle AERs (271 confirmed metal). In 2009, just 315 (135 confirmed metal) AERs were made involving the Pinnacle Hip Implant.
DePuy Pinnacle Hip Implants are also sold with ceramic and polyethylene liners. But these versions don't appear to be attracting the same number of complaints. Only one of the 709 DePuy Pinnacle Hip Implant AERs in the last three months identified a polyethylene liner. In the last decade, only six AERs have identified a polyethylene liner (one in 2006, two in 2010, and three in 2011.) In the same period, only one - in 2011 - identified a ceramic liner.