Description of Event or Problem · 1
PINNACLE AND SUMMIT HIP REPLACEMENT SYSTEMS IMPLANTED IN PT WERE INEFFECTIVE, FAILED TO RESOLVE HIP AND GROIN PAIN, FAILED TO RESTORE HIP FUNCTION AND RANGE OF MOTION WITHOUT PAIN, REQUIRED FURTHER MEDICAL TREATMENT, INCLUDING REVISION SURGERY. PT EXPERIENCED INCREASING LEFT HIP PAIN AND GROIN PAIN IN LEFT HIP FROM 2006. PT TREATED WITH PAIN MEDICATION, ANTI-INFLAMMATORIES, AND REDUCED IMPACT ACTIVITIES. PT DIAGNOSED WITH SEVERE DEGENERATIVE ARTHRITIS AROUND (B)(6) 2007. PT UNDERWENT A FULL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. HARDWARE INSTALLED ON (B)(6) 2007 INCLUDED PINNACLE SECTOR II ACETABULAR CUP, M-SPEC FEMORAL HEAD, SUMMIT TAPERED HIP STEM, AND PINNACLE CANCELLOUS SCREW. PT TREATED WITH PHYSICAL THERAPY, ICE FOR PAIN, PAIN MEDICATION, USED A CANE, DAILY RANGE OF MOTION EXERCISES, HIP PRECAUTIONS, PHYSICAL THERAPY. PT WAS NOT ABLE TO RETURN TO ATHLETIC ACTIVITIES, AND HAD DIFFICULTY WITH DAILY FUNCTIONING DUE TO HIP PAIN. (B)(6) MONTHS LATER, (B)(6)2008, PT'S MOBILITY AND COMFORT NOT RESTORED; PT EXPERIENCED DISCOMFORT WHEN TRYING TO RUN. PHYSICIAN ORDERED EXTREMELY FREQUENT X-RAYS AND, EVENTUALLY, A BONE SCAN TO EVALUATE FOR POSSIBLE LOOSENING OF IMPLANTS. X-RAYS WERE TAKEN DURING EACH ROUTINE SURGERY F/U VISIT TO INVESTIGATE PROBLEMS AND PAIN. X-RAYS EXPOSED PT TO RADIATION EXCESSIVELY, AND RESULTED IN ADD'L INSURANCE COSTS EACH TIME. BONE SCAN SHOWED NO EVIDENCE OF LOOSENING. PT TREATED WITH ANTI-INFLAMMATORIES AND ICE, AS WELL AS ABOVE TREATMENTS, THERAPIES AND MEDICATIONS. PT WAS NOT ABLE TO RETURN TO ATHLETIC ACTIVITIES, AND HAD DIFFICULTY WITH DAILY FUNCTIONING DUE TO HIP PAIN. (B)(6) YEAR LATER, (B)(6) 2008, PT STILL COMPLAINED OF GROIN PAIN, ESPECIALLY WITH AN ACT AS SIMPLE AS "RUNNING ACROSS THE STREET". RANGE OF MOTION EXAM REVEALED HIP PAIN AT THE EXTREMES. ON (B)(6) 2008, PT HAD PAIN WITH WEIGHT BEARING ACTIVITIES AND ANY MOTION REQUIRING HIP FLEXION. ON (B)(6) 2009, PT WAS REEVALUATED FOR CONTINUED HIP PAIN, INCLUDING WHEN GETTING UP FROM A SEATED POSITION AND LAYING ON HIS LEFT SIDE. PT WAS STILL UNABLE TO RETURN TO ATHLETIC ACTIVITIES, AND HAD DIFFICULTY WITH DAILY FUNCTIONING DUE TO HIP PAIN. AN APPOINTMENT WAS MADE FOR A SECOND OPINION WITH ANOTHER ORTHOPAEDIC SURGEON. IMPLANTATION OF THE DEVICE CAUSED DAMAGE TO PT'S FEMUR, DAMAGING AND DISRUPTING PT BODY STRUCTURE AND DAILY FUNCTION. PT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION DUE TO DEGENERATIVE ARTHRITIS BEFORE SURGERY. HOWEVER, EVEN DAILY FUNCTIONING WAS EXTREMELY PAINFUL AND FURTHER LIMITED BY INCREASED HIP AND GROIN PAIN, LIMITED RANGE OF MOTION, AND INABILITY TO BEAR WEIGHT ON LEFT HIP/LEG AFTER IMPLANTATION OF DEVICES. AFTER GETTING A SECOND OPINION, IT WAS DETERMINED THAT SURGICAL INTERVENTION WAS NECESSARY TO PREVENT FURTHER DISABILITY OR PERMANENT DAMAGE TO THE PT'S BONE STRUCTURE. EXAMINATION BY ORTHOPAEDIC SURGEON REVEALED "SMALL GAP" AND "LIGHT SPOTS AROUND THE TOP OF THE STEM" INDICATING LOOSENING, WHERE STEM WAS EITHER NOT FITTED CORRECTLY, OR THE DESIGN OF THE STEM CAUSE WEAR OF THE SURROUNDING TISSUE AND BONE, WIDENING THE FEMUR OPENING. SURGEON RECOMMENDED REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2009. A SEPARATE COMPLAINT HAS BEEN FILED DUE TO FAILURE WITH THAT SURGERY AS WELL. THE SUMMIT HIP STEM BECAME DISPLACED, AND CAUSING PAIN, A "CLICKING" SOUND, AND A "RESETTING" SENSATION EACH TIME PT STOOD UP FROM A SITTING POSITION, OR TRIED TO RUN OR PUT WEIGHT ON LEFT LEG. EXAMINATION BY ORTHOPAEDIC SURGEON REVEALED "SMALL GAP" AND "LIGHT SPOTS AROUND THE TOP OF THE STEM" INDICATING LOOSENING, WHERE STEM WAS EITHER NOT FITTED CORRECTLY, OR THE DESIGN OF THE STEM CAUSE WEAR OF THE SURROUNDING TISSUE AND BONE, WIDENING OF THE FEMUR OPENING. A BLOOD TEST WAS CONDUCTED ON (B)(6) 2011, FOR METALLIC IONS IN THE BLOOD. TEST SHOWED PT HAD ELEVATED OUT OF RANGE COBALT LEVELS. THE PINNACLE ACETABULAR CUP WITH A METAL LINER WAS USED WITH A SUMMIT HIP STEM, A METAL-ON-METAL SYSTEM. THE METAL LINER ON THE PINNACLE CUP DISASSOCIATED OVER TIME, CAUSING INCREASED COBALT LEVELS IN PT'S BLOOD, AN UNEXPECTED AND DANGEROUS SIDE EFFECT OF THE HIP REPLACEMENT SYSTEM. PT NOW UNDERSTANDS COBALT TO BE A CARCINOGEN; THIS RISK WAS NOT DISCLOSED TO PT WHEN PT WAS ASKED TO GIVE INFORMED CONSENT TO RECEIVE THE SYSTEM PRIOR TO SURGERY. FURTHERMORE, AS EVIDENCE THAT THE PINNACLE HIP STEM WITH THE PINNACLE SECTOR II CUP DOES NOT WORK AND CAUSES METALLOSIS, PT REVIEWED A (B)(6) 2010 MAUDE ADVERSE EVENT REPORTS WHICH INDICATED AT LEAST ONE CONSUMER COMPLAINING OF "RHYTHMIC POPPING AND INSTABILITY" AND "BELIEF THAT HARDWARE IS FAULTY". HIP ASPIRATION AT ONE YEAR IN THAT PT SHOWED THAT METAL SHAVING WERE PRESENT IN PT'S BLOOD. MAUDE REPORT WAS MADE FIVE AND A HALF YEARS AFTER THE IMPLANT. IN THAT CASE, THE SUMMIT CANCELLOUS SCREW AND THE SUMMIT OFFSET WERE ALSO REPORTED AS FAULTY. AS FURTHER EVIDENCE THAT PINNACLE SECTOR II CUPS ARE FAULTY, MAUDE ADVERSE EVENT REPORTS FILED (B)(6) 2007, (B)(6) 2007, (B)(6) 2008, (B)(6) 2009, AND (B)(6) 2010 INDICATE THAT THE CUPS ARE PRONE TO DISLOCATION OR DISLODGING REQUIRING SURGICAL INTERVENTION. IN ONE CASE, "A CRACK WAS NOTICED IN THE POSTERIOR WALL OF THE ACETABULUM" ((B)(6) 2008). USERS EXPECT THAT HIP REPLACEMENT SYSTEM WILL REDUCE PAIN AND IMPROVE QUALITY OF LIFE. WHILE THERE IS NO GUARANTEE THAT 100% OF CASES WILL BE PERFECTLY UNEVENTFUL, PT AND PHYSICIANS IN THIS INSTANCE CANNOT FIND ANY REASON PT'S PAIN WOULD BE INCREASING, ANY REASON THAT PT WOULD HAVE SUCH EXTREME DIFFICULTY IN SIMPLE DAILY FUNCTIONING, WHY PT FELT "CLICKING", EXPERIENCED "RESETTING" IN THE HIP STEM WHEN STANDING AND WALKING. NOT ONLY IS THE HIP REPLACEMENT OPERATING DIFFERENTLY THAN EXPECTED, BUT THE EFFECTS ARE INCONSISTENT WITH PT'S INTUITION OF "HOW IT SHOULD BE". IN ADDITION, BONE SCANS, MRI'S, AND X-RAYS WERE UNABLE TO IDENTIFY A PROBLEM, BUT ORTHOPAEDIC DR LATER SPOTTED A "SPACE" BETWEEN STEM AND FEMUR AT POINT OF INSERTION, WHICH IS UNEXPECTED AND EXPLAINS THE PAIN AND OTHER SYMPTOMS. AS STATED ABOVE, A BLOOD TEST WAS CONDUCTED ON (B)(6) 2011 FOR METALLIC IONS IN THE BLOOD. A BLOOD TEST FOR COBALT AND CHROMIUM IN THE BLOOD WAS RECOMMENDED BY THE MFR, DEPUY ORTHOPEDICS, ON ITS WEBSITE. TEST SHOWED PT HAD ELEVATED OUT OF RANGE COBALT LEVELS. THE PINNACLE ACETABULAR CUP WITH A METAL LINER WAS USED WITH A SUMMIT HIP STEM, A METAL-ON-METAL SYSTEM. THE METAL LINER ON THE PINNACLE CUP DISASSOCIATED OVER TIME, CAUSING INCREASED COBALT LEVELS IN PT'S BLOOD, AN UNEXPECTED AND DANGEROUS SIDE EFFECT OF THE HIP REPLACEMENT SYSTEM. PT NOW UNDERSTANDS COBALT TO BE A CARCINOGEN; THIS RISK WAS NOT DISCLOSED TO PT WHEN PT WAS ASKED TO MAKE INFORMED CONSENT TO RECEIVE THE SYSTEM PRIOR TO SURGERY. PRODUCT LABELING AND PACKAGING IS CONFUSING AND INADEQUATE FOR FAILING TO WARN PTS OF SUCH RISKS. IN ADDITION, PT UNDERSTOOD HIP REPLACEMENT SYSTEM WOULD LAST 15 YEARS OR MORE, BUT SYSTEM FAILED WITHIN SIX MONTHS. DOSE OR AMOUNT: 1 UNIT, FREQUENCY: NA, ROUTE: (B)(6) -SURGICAL IMPLANT; 1 UNIT, NA, (B)(6) -SURGICAL IMPLANT. DATES OF USE: (B)(6) 2007 TO PRESENT; (B)(6) 2007 TO (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: DEGENERATIVE ARTHRITIS L HIP; TOTAL L HIP ARTHROPLASTY; DEGENERATIVE ARTHRITIS L HIP; TOTAL L HIP ARTHROPLASTY. EVENT ABATED AFTER USE: NO.