Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, June 2, 2017

27% Device Failure Rate: Johnson & Johnson DePuy Pinnacle

June 1, 2017
VIENNA — Patients treated at a single center with one brand of metal-on-metal total hip replacement had a statistically significantly greater risk of implant failure if they had bilateral surgery or were operated on in 2006 or later, according to the 10-year results Gulraj S. Matharu, BSc (Hons), MBChB, MRCS, of Oxford, United Kingdom, presented 31 May, at the 18th EFORT Annual Congress in Vienna.

The 569 patients studied retrospectively had standard demographics, he said. They underwent THR with the Pinnacle prosthesis (DePuy Synthes) with a 36-mm cobalt chrome head and an uncemented Corail stem (DePuy Synthes).

Gulraj S. Matharu

“This large cohort study of Pinnacle metal-on-metal (MoM) [total hip replacements] THRs has confirmed a high failure rate at 10 years with this device, but it is especially seen if the Pinnacle was put in from 2006 onwards and in bilateral MoM hip patients. This supports the recent and serious concerns about potential manufacturing differences in more recent years,” Matharu said.
Some of those problems led to edge loading and/or high friction, he noted.
In the first 4 years of the implantations, “there was no significant difference in failure rate between the early and late implantations,” Matharu said.
“Seventeen percent of our cohort were failures, the majority of these being for [adverse reaction to metal debris] ARMD, which is unsurprising,” he said, noting 72 patients (12.7%) had a failed THR due to ARMD. – by Susan Rapp


Matharu GS, et al. Paper #710. Presented at: 18th EFORT Annual Congress: 31 May - 2 June 2017, Vienna.

Disclosure: Matharu reports no relevant financial disclosures.

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