IN 2009, THE PATIENT'S PROSTHETIST JACK PRANZARONE NOTIFIED OUR CONSULTING PROSTHETIST REP THAT THE OUR PLIE' MICROPROCESSOR-CONTROLLED KNEE (DEVICE) BUCKLED WHEN THE PATIENT FELL IN HIS HOME ONE MONTH PRIOR. TO DATE WE HAVE RECEIVED NO OBJECTIVE EVIDENCE THAT THE PATIENT SUFFERED INJURY AS A RESULT OF THE FALL. DURING THE FOLLOWING MONTH, INITIAL REPORT, REP REPORTED THAT THE PATIENT SUFFERED DAMAGED CERVICAL TISSUE AND LOSS OF SPINE STABILITY SUBSEQUENT TO THE FALL THAT WILL REQUIRE SURGERY TO CORRECT, HOWEVER, REP DECLINED TO ASSERT THAT DEVICE MALFUNCTION CAUSED THE FALL. DURING THE SAME MONTH, CONVERSATION WITH OUR NATIONAL SALES MANAGER, THE INITIAL REPORTER, ASSERTED THAT, DURING APPOINTMENTS SUBSEQUENT TO THE FALL, THE PATIENT HAD NOT ATTRIBUTED HIS FALL TO DEVICE MALFUNCTION.
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Patient 1
CONCLUSION: DEVICE DAMAGED SUSTAINED IN THE FIELD WHILE IN USE BY THE PATIENT. DAMAGE BELIEVED TO BE RESULT OF EVENT RATHER THAN CAUSAL TO EVENT. IN SUMMARY, THE MAJORITY OF THE DAMAGE IS CONSISTENT WITH A SINGLE FALL, IN WHICH THE PATIENT FELL ON THE KNEE CAP HARD ENOUGH TO CRACK THE REAR SURFACE OF THE BATTERY BOX, AND BREAK THE POSITION SENSOR MOUNTING. HOWEVER, THE KNEE SHOWS EVIDENCE OF MULTIPLE IM-PACTS. AS A RESULT, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE POSITION SENSOR BREAKAGE OCCURRED BEFORE OR DURING THIS INCIDENT. IN GENERAL, IT IS POSSIBLE THAT, AFTER A POSITION SENSOR MOUNT HAS BROKEN, A KNEE MAY CONTINUED TO WORK INTERMITTENTLY OR WELL FOR AN INDETERMINATE PERIOD OF TIME. WHEN THE POSITION SENSOR FAILS AS SEEN IN THIS INSPECTION, THE KNEE BECOMES STIFF AND LESS SUSCEPTIBLE TO FALLS. OIL LOSS CAUSED BY DAMAGE TO THE SHAFT COULD CONTRIBUTE TO THIS EVENT. SOME LOSS OF OIL WAS APPARENT. IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OR TIMING OF THE DAMAGE TO THE SHAFT. THE KNEE IS REPAIRABLE.