FDA orthopedic advisory panel recommends approval of ceramic-on-metal implant for hip replacement

The Orthopaedic and Rehabilitation Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously yesterday to approve recommendation of the Pinnacle CoMplete Acetabular Hip System (DePuy), the first ceramic-on-metal hip bearing to be considered for approval in the United States.

The approval came with three conditions, all of which were approved unanimously:

The labeling of the product must be changed so that it is equivalent to DePuy's metal-on-metal bearing in regard to the serum metal ion conditions.
A postapproval study that includes serum ion levels and a 10-year follow-up must be initiated. DePuy will be expected to work with the FDA and recognized experts to organize the study and work out control group conditions.
The patient information included with the implant must be made more patient-friendly, stating information generically and on an appropriate reading level.

The panel saw testimony that included study results comparing the safety and efficacy of the ceramic-on-metal implant to that of a DePuy metal-on-metal implant. Those results reportedly showed no significant difference in adverse events, revision rates or survivorship over a 2-year period. Patients also reportedly experienced similar pain relief as well as improved function and range of motion.

Mixed feelings

The panel expressed satisfaction with the presentation and PMA, although numerous panel members and representatives expressed concern over the information included with the implant itself, leading to the conditions requested.

“I was very impressed with the safety issues that were brought up,” Karen Rue, a consumer representative, said prior to the conditions’ approval. Rue went on to express “significant concerns with the patient information that has been included in regards to what was included, what was not included and the verbiage that was used.”

Panel member Harry B. Skinner, MD, PhD, said in his final comments that he was pleased by what he had seen.

“I think that the PMA was remarkably well done,” he said. “I think the information provided demonstrated that it was safe and efficacious as an implant system, and I think the amendments that were made — which were relatively minor and certainly not very contentious — will be a significant improvement to the PMA.”

“The sponsor showed safety and efficacy, and I’d like to thank them for being so responsive to the questions [of the panel],” panel member Timme Topoleski, MD, PhD, added.

DePuy pleased with the decision

DePuy expressed their appreciation for the panel’s decision, claiming that FDA approval of the implant would be a large step for the advancement of hip replacement.

“We are pleased with the panel's recommendation, and if approved by the FDA, the Pinnacle CoMplete System would represent an important innovation for hip replacement in the United States,” Pamela Plouhar, PhD, vice president of worldwide clinical affairs for DePuy, said in a press release. “Each new implant provides orthopedic surgeons and their patients more choices, which result in more individualized treatment based on specific patient anatomy, lifestyle, age, medical condition and surgeon preference.”

The Pinnacle CoMplete System is currently limited by U.S. law to investigational use only. A DePuy ceramic-on-metal bearing has been marketed in 40 countries outside the United States since 2007, according to the press release.