Description of Event or Problem · 1
ON (B)(6) 2011 AND (B)(6) 2012, I UNDERWENT SURGERY TO REPLACE MY LEFT AND RIGHT HIPS DUE TO BILATERAL HIP DEGENERATIVE JOINT DISEASE LIMITING MY ABILITY TO WALK. THE ARTHROPLASTIES PROVIDED ME WITH AN OMNI-ARC STEM. BIOLOX HEAD AND A ZIMMER CONTINUUM CUP WITH A LINER AND CANCELLOUS SCREWS. ON (B)(6), 2017 I SOUGHT CARE FROM AN ORTHOPEDIC SURGEON AT THE (B)(6). X-RAYS SHOWED THE HIP INTACT, HOWEVER. LAB RESULTS FOR METALLOSIS ELEVATED LEVELS OF COBALT IN MY BLOOD DUE TO THE METAL ON METAL HIP PROSTHESIS. AN MRI ON (B)(6) 2017 INDICATED A PSEUDOTUMOR NEAR THE RIGHT HIP IMPLANT. SERUM LAB TESTS ON (B)(6) 2017 SHOWED INDICATORS FOR INFECTIOUS PROCESS. ON (B)(6) 2017, THE SURGEON EXPLANTED THE RIGHT HIP FAILED HARDWARE AND · PATHOLOGY REPORTS DURING SURGERY INDICATED PRESENCE OF INFECTED TISSUE. THE HIP WAS REPLACED WITH A SPACER INFUSED WITH ANTIBIOTICS. ON (B)(6) 2017, THE SURGEON PERFORMED AN ARTHROSCOPY AND REPLACED THE SPACER WITH NEW PROSTHETIC JOINT. ON (B)(6) 2012, AN OPERATION WAS PERFORMED TO REPLACE MY RIGHT HIP DUE TO THE DEGENERATIVE JOINT DISEASE SECONDARY TO OSTEONECROSIS (STAGE VI AVASCULAR NECROSIS). THIS ARTHROPLASTY ALSO PROVIDED ME WITH AN OMNI-ARC STEM, BIOLOX HEAD AND A ZIMMER CONTINUUM CUP WITH A LINER AND CANCELLOUS SCREWS. THE OMNI-ARC STEM AND BIOLOX HEAD ARE PRODUCTS OF OMNLLIFE SCIENCE, INC. THESE IMPLANTS WERE EXPECTED TO HAVE A 10-15-YEAR USEFUL LIFE SPAN. BOTH LEFT AND RIGHT HIP ARTHROPLASTY PROCEDURES WERE CONDUCTED AT (B)(6). IN (B)(6) 2017, INCREASING PAIN AND DISCOMFORT IN MY RIGHT HIP WAS RESTRICTING MOBILITY AND NEGATIVELY IMPACTING MY QUALITY OF LIFE. ON (B)(6) 2017, I SOUGHT CARE FROM AN ORTHOPEDIC SURGEON AT THE (B)(6) AND X-RAYS SHOWED THE HIP WAS INTACT. HOWEVER, LAB RESULTS FOR METALLOSIS SHOWED ELEVATED LEVELS OF COBALT IN MY BLOOD MOST LIKELY DUE TO THE METAL ON METAL FROM THE HIP PROSTHESIS. AN MRI ON (B)(6) 2017 INDICATED A PSEUDO-TUMOR NEAR THE RIGHT HIP IMPLANT. SERUM LAB TESTS ON (B)(6) 2017 SHOWED INDICATORS FOR AN INFECTIOUS PROCESS AND ADDITIONAL LABS ON (B)(6) 2017 SHOWED AN INCREASE IN THE INFECTIOUS PROCESS INDICATORS. ON (B)(6) 2017, I UNDERWENT A RIGHT HIP ASPIRATION USING ULTRASOUND GUIDANCE AT THE UNIVERSITY OF UTAH ORTHOPEDIC CENTER. NO FLUID WAS ASPIRATED AFTER TWO ATTEMPTS, BUT THE FINDINGS WERE SUSPICIOUS FOR ADVERSE LOCAL TISSUE REACTION. PRE-OP LABS ON (B)(6) 2017, SHOWED SYSTEMIC INDICATORS OF INFLAMMATION AND ON (B)(6) 2017 THE SURGEON EXPLANTED THE RIGHT HIP HARDWARE AND PATHOLOGY REPORTS DURING SURGERY INDICATED PRESENCE OF INFECTED TISSUE. THE FAILED HIP IMPLANT WAS REPLACED WITH AN ANTIBIOTIC INFUSED SPACER TO ADDRESS THE INFECTIOUS PROCESS. IN ADDITION, A PIC LINE WAS INSERTED ON (B)(6) 2017 TO FURTHER TREAT INFECTED TISSUE USING A 6-WEEK IV REGIMEN OF VANCOMYCIN. I WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017 AND BEGAN A 12-WEEK PERIOD OF NON WEIGHT BEARING ON MY RIGHT LEG. FOLLOW-UP CARE REQUIRED TWICE A DAY INFUSION OF THE VANCOMYCIN VIA THE PIC LINE AND WEEKLY VISITS FROM A HOME HEALTH RN TO CHANGE THE DRESSING AND CHECK LABS FOR TOXICITY FROM THE VANCOMYCIN. THIS CARE PROCESS WITH THE NON-WEIGHT BEARING RESTRICTIONS SEVERELY LIMITED MY ABILITY TO RETURN TO WORK AND ALSO RESTRICTED MY SPOUSE'S ACTIVITIES SINCE HE WAS THE DAILY CARE-GIVER ADMINISTERING THE VANCOMYCIN EVERY 12 HOURS. AN INFECTIOUS DISEASE SPECIALIST AND THE INFUSION TEAM WORKING WITH THE SPECIALIST ALSO TREATED ME DURING THIS PROCESS. AFTER COMPLETING THE IV PROGRAM AND A 6-WEEK INFECTION-FREE PERIOD, THE SURGEON PERFORMED AN ARTHROSCOPY AND REPLACED THE SPACER WITH A NEW PROSTHETIC JOINT ON (B)(6) 2017. ALTHOUGH USE OF METAL ON METAL (MOM) PROSTHETICS FOR HIP REPLACEMENTS HAS DECLINED SINCE 2011, BECAUSE OF POST-OP COMPLICATIONS LIKE MINE, MY REVIEW OF SCIENTIFIC LITERATURE ABOUT THESE TYPES OF IMPLANTS SHOWS THEY ARE USUALLY LIMITED TO HIP RESURFACINGS FOR WHICH THERE IS NO OTHER EQUIVALENT ALTERNATIVE. MY SEARCH ALSO INDICATED FOR MOM IMPLANTS THE US (B)(6) RECOMMENDED MANAGEMENT FOR THESE DEVICES FOR ASYMPTOMATIC PATIENTS TO INCLUDE ANNUAL ORTHOPEDIC FOLLOW-UP INCLUDING TESTING FOR COBALT AND CHROMIUM TOXICITY. I WAS NOT ADVISED TO GET ANNUAL F/U, NOR DID I RECEIVE ANY LAB TESTING UNTIL I DEVELOPED PAIN AND AN INFECTION IN MY HIP. I AM NOW BEING EVALUATED ANNUALLY WITH EXAMINATIONS AND LAB TESTING FOR METALLOSIS, SINCE MY ORIGINAL LEFT HIP REPLACEMENT REMAINS IN PLACE. ALSO A NEUROLOGIST IS TREATING ME WITH ATTENTION TO LONG-TERM EFFECTS OF METALLOSIS. I URGE YOU TO INVESTIGATE THESE DEVICES AND TO REMOVE THEM FROM THE MARKET IF WARRANTED.