Anatomy of a Deceptive Direct to Consumer Robotic Surgery Marketing Campaign – Superior Implant Survivorship In November 2012, MAKO Surgical Corp. (Fort Lauderdale, FL) added a document to its website titled MAKOplasty Clinical Highlights Survivorship Data 1. The document includes two slides. Slide 1 references a 0.4% 2-year cumulative revision rate (CRR) observed in what is [...]
January 15, 2013
MAKO Surgical Recall Excludes Five RIO Robotic Arm Systems Recalled in 2011
· (Updated: March 27, 2013)
On February 1, 2011 MAKO Surgical sent a Recall Notice to its customers. The recall stemmed from an issue where, under certain circumstances, “the error value calculated by the RIO system could be incorrect” leading to “a possible incorrect interpretation of the registration accuracy of the RIO system, which could then result in bone resection that [...]
January 7, 2013
MAKOplasty Procedure Growth and System Utilization in Decline
· (Updated: March 28, 2013)
Domestic MAKOplasty Procedure Growth MAKOplasty Utilization – RIO Robotic Arm Utilization – Knee Procedures Tweet
December 3, 2012
Cherry Picking Clinical Nuggets – MAKOplasty Clinical Highlights Restoris MCK Medial Onlay Has Only 0.4% 2-Year Revision Rate
· (Updated: April 3, 2013)
2-Year Outcomes of Robotic Arm Assisted Unicompartmental Knee Arthroplasty In early November 2012, MAKO Surgical uploaded a new PDF document (MAKOplasty Clinical Highlights Survivorship Data) dated 10/23/2012 that reports two-year survivorship rates for 201 patients, operated on by four MAKOplasty surgeons, who were implanted with MAKO’s RESTORIS MCK Medial Onlay. According to the document, the MCK Medial [...]
November 14, 2012
Surgeon Led to Believe RIO System Malfunction Bizarre Event
· (Updated: April 15, 2013)
Surgeon Wants FDA to Have More Accurate Understanding of Scope RIO Robotic Arm System Malfunction FDA’s MAUDE Adverse Event database was updated last week and now includes the complete set of 120 MAKOplasty MDRs that MAKO Surgical Corp. disclosed it had filed in its 10-Q dated May 7, 2012. A recap of the disclosure appears [...]
