Partner with TrackMy ® to resolve these REAL issues.Turn over for our vision and who/how we help…

REAL PATIENT IMPACTYears passed, and the hip “never really got better,” Roche recalled. So he wasn’t surprised around three years later when he turned on the TV and saw news of a recall on the DePuy Orthopaedics ASR implant that had brought him so much pain. “I was thinking, ok, I’m not crazy. This is actually a real problem,” Roche said.-Dermot Roche (TrackMy Patient)

Dermot was featured on TrackMy Solutions Podcast #4. Listen HERE

I believe they were what made me start having EXTREME symptoms and pain from 2011-2017. I want to report this to Health Canada as it’s very important they keep record of adverse effects but I can’t give them any information because the hospital mistakenly didn’t put the medical device stickers in my file!-TrackMy Patient (Actual Patient)

RECONCILING RECENT RECALL LITIGATION$80 Million verdict in Ethicon proleft pelvic mesh lawsuit.Real Issues - The most serious of these, according to the FDA, are infection, pain, urinary problems, scarring and recurrence of prolapse and or incontinence. The mesh also erodes, gradually dislodging where it was implanted and moving into the surrounding tissue and organs.

Eighth time a Philadelphia court has sided with women suing Ethicon for mesh injuries. This latest jury award brings the total judgments so far to more than $346 million.

As of April 2019, more than 11,000 lawsuits were pending in federal court against the manufacturers of IVC Filters by individuals who claim to have experienced various injuries.

MANAGING PROVIDERLIABILITY RISKSCourts have held that a health care provider can be liable for failing tomake reasonable efforts to warn an affected patient of a recall where the provider receives notice of such recall and is instructed as part of the FDA established recall plan to notify patients.

Seeing patients with recalled devices as soon as possible can increase the positive outcome expectation (avoiding death) drastically. By age, the mortality rate after revision surgery was:• 15 percent for patients younger than 70• 87 percent for patients older than 80

METAL ON METAL HIP IMPLANTSIn addition to the litigation that DePuy is still involved with, other metal-on-metal hip replacement manufacturers are facing lawsuits related to the high failure rate.

In 2012, Stryker voluntarily recalled its Rejuvenate and ABG II hip implants, citing the risk of corrosion. The company estimates that costs related to the recall and accompanying litigation could climb as high as $1.13 billion.

Zimmer is in early stages of litigation over two modular implants that utilize its Kinectiv Technology, the M/L Taper Hip Prosthesis & CLS Brevius Stem.

Biomet is being sued over its M2A-Magnum hip replacement system. The lawsuits have been consolidated into an MDL in ID. Biomet has not issued a recall.

Between 2009 and 2012, Smith & Nephew recalled the metal liners in its R3 Acetabular System, citing evidence of high failure rates in UK and Australian patient registries. As of November 2013, extensive litigation has notbeenfiledagainstthecompany. A judge in Illinois recently dismissed a suit based onalackofspecificityintheplaintiff’s allegations.

MEDICAL DEVICE NEWSRECALLS & LAWSUITS ON THE RISE

TrackMy Solutions • TrackMySolutions.us • 2019

Recalls on the Rise!

George Ball - https://theconversation.com/recalls-of-medical-devices-and-drugs-are-up-can-anyone-predict-when-it-will-happen-next-115832

Medical Device RecallsThe number of medical device recalls reported to the FDA has increased in recent years.

All data points discussed are articles found through independent research and compiled into this document. Sources available upon request.

DEVICE MANUFACTURERSSURGEONS/PHYSICIANSHEALTH PLANS

Patients

WHO | HOW | WHY

SOLVING THE GAPWHO DO WE HELP?• Hospital Systems• Surgery Centers• Surgeons• Health Plans• Patients• Physical Therapists• Home Health (Long term care)• Supply Chain/Inventory

HOW?INCREASE REVENUE• Be a differentiator using

TrackMy – ‘Safer Surgeon’ Program

• Reduce Re-admissions• Decrease operating room

time for revisions

DECREASE COST• Reduce unnecessary procedures (time savings/

cost; Bundled Payments/Value-based care)• Reduce time in surgery (FTE Cost; by proper

surgical planning and knowing what patient has)• Build trust through improved communication –

meet patient expectations

IMPROVE OUTCOMES• Increased client satisfaction• Liability reduction• Enhance public safety• Do the ‘right’ thing• Partner with TrackMy to be your recall strategy

ENHANCE WORKFLOWS• Improved Physician documentation and

throughput• Surgeontopatientflow• Reduce operating room time• Educate patients• Leading edge of Regulatory

TRACKMY® IMPLANTS TECHNOLOGYCURRENT STATE – User Search and Save (leverages GUDID API) Electronic Implant ID Card

• Partnerships with Surgeons to upload Device data into TrackMy

• Patient Consents through PreOp Checklist Form• TrackMy uploads Implant Record into Patient TrackMy

Account through secure process• Patient/Surgeon/HealthPlan–receivesNotificationif

Device has been recalled through TrackMy patent-pending algorithm; Patient has Electronic Implant ID Card

IMMEDIATE FUTURE STATE - • SmartonFHIRIntegration(tofulfillPromoting

Interoperability Patient Access Regulatory requirements) with Electronic Medical Records to pull Device Data, & other key elements into TrackMy

• Early adopter with Meditech Expanse• Sandbox Integration build complete with Allscripts & Epic• Other target EMRs in process

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PATIENT IMPLANT ID CARD

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DEVICE IMPLANT ID CARD

Patient: Tom RandelPhysician: Dr. Aakash ShahPatient Phone: 913-555-5555...............................................................

MFG Product Model UDIStryker Total Hip 5684932 A459-9392-1Stryker Knee 981930 KZR-920485322Endo Pacemaker 920452800 R2-56890-S4

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This patient has been implanted with the following medical devices.

VISION

*Double E, Double i of Healthcare TrackMy Mission Statement - Engagement of individuals and communities to be more educated, make informed decisions & have more involvement in the management of their health.

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