PATIENT IS CURRENTLY NOT HAPPY WITH THE AMOUNT OF PAIN RELIEF SHE IS ABLE TO GET AFTER THE SURGERY. BUT, SATISFIED WITH THE RANGE OF MOTION. THE TREATING SURGEON SCHEDULED PATIENT FOR RE-CEMENTING THE COMPONENTS. ARTHROSURFACE IS FOLLOWING UP WITH THE PATIENT AND MONITORING THE PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED AS REQUIRED TO PROVIDE UPDATES ON PATIENT'S CONDITION. FOLLOWING ARE THE DETAILS OF COMPONENTS IMPLANTED IN THE PATIENT: PART # 9M52-2535-W LOT # 75JD2904 MFG DT: 12-2014 EXP DT: 12-2021. PART # 9095-0018-W LOT # 75BE2522 MFG DT: 03-2015 EXP DT: 03-2020. PART # 9P15-S180-A LOT # 75ID0436 MFG DT: 09-2014 EXP DT: 09-2019. PART # 9P15-PB01-A LOT # 75ID0208 MFG DT: 10-2014 EXP DT: 10-2019.
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Patient 1
PATIENT CONTACTED ARTHROSURFACE TO REPORT PAIN AND OTHER ON-GOING ISSUES ASSOCIATED WITH THE RIGHT TOE AFTER HAVING IMPLANTED WITH TOE MOTION COMPONENTS. PATIENT WANTS TO BE HEALTHY, NOT BE IN CONSTANT PAIN AND IS LOOKING FOR ANY ADVICE THAT ARTHROSURFACE COULD PROVIDE WITH REGARD TO THOSE ISSUES.
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Patient 1
THE PATIENT WAS REVISED TO A NON-ARTHROSURFACE TOE IMPLANT ON (B)(6) 2015. THE ARTHROSURFACE COMPONENTS WERE REMOVED FROM THE PATIENT AND THE REVISION WAS COMPLETED WITHOUT ANY ISSUE. IT IS NOT KNOWN HOW THE IMPLANT LOOSENED. PATIENT HAS HAD MULTIPLE SURGERIES BEFORE AND AFTER SEVERAL DISCUSSIONS, WE LEARNED THAT PATIENT HAS A DEVICE LOOSENING HISTORY. GIVEN PATIENT'S DEVICE LOOSENING HISTORY AND EARLY WEIGHT BEARING, IT IS POSSIBLE THAT IMPLANT MIGHT HAVE LOOSENED. THE COMPLAINT IS CONSIDERED CLOSED AT THIS TIME.
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Patient 1
THIS SUPPLEMENTAL REPORT IS BEING FILED AS PER PATIENT'S RECENT ((B)(6) 2015) EMAIL REGARDING THE DATE OF REVISION SURGERY. THE REVISION DATE WAS CORRECTED TO (B)(6) 2015. WORK-UP FOR RULING OUT ANY INFECTIONS AND METAL ALLERGY HAD BEEN DONE PRIOR TO THE REVISION DATE. ON (B)(6) 2015, PATIENT MET SURGEON FOR ANESTHESIA AND PRE-OP CHECK UP. NO OTHER REPORTABLE INFORMATION.