Description of Event or Problem · 1
OPERATION IN 2002 INSERTED SULZER MEDICA UNISPACER KNEE SYSTEM UNISPACER RIGHT MEDIAL. PATELLAR SURFACE SHOWED GRADE 1 CHONDROMALACIA CHANGES AT THE TROCHLEA. DEBRIDEMENT WAS DONE OF THE MENISCUS. THE ARTICULAR SURFACE ON BOTH THE TIBIAL SIDE AND FEMORAL SIDE SHOWED CHONDROMALACIA CHANGES, MOSTLY ON THE TIBIAL SIDE WITH BARE BONE CHANGES HERE. GRADE 3 AND 4 CHANGES ON THE MEDIAL FEMORAL CONDYLE. THE SURFACE OF THE TIBIA AS WELL AS THE FEMUR WAS MILLED WITH A POWER RASP AND CURETTE BLADE. INSERTED A 54 = TMM UNISPACER. TECH REP FOR SULZER SAID TO PULL OUT AND MORE DEBRIDEMENT WAS DONE UNTIL FINALLY FIT WITH THE 54X4MM TRIAN COMPONENT. THIS OVERHUNG AN APPROPRIATE AMOUNT POSTERIOR IN FLEXION AND TO TRAVEL IN EXTENSION. A CHONDROPLASTY WAS DONE IN THE TROCHLEA IN A POSITION WHERE THE COMPONENT COULD CONTACT THE DISTAL FEMUR IN FULL EXTENSION. IT WAS STAPLED. PT RELEASED, THEN SUFFERED EXCUCIATING PAIN, SWELLING, INABILITY TO PUT FULL WEIGHT ON IT, LOSS OF APPETITE, LOSS OF SLEEP, TOLD NOTHING WAS WRONG THAT IT WOULD BE FINE IN 4 MONTHS. IN 2003 BECAUSE OF EXTREME PAIN AND NEED FOR HIGH DOSES OF NARCOTICS, UNISPACER WAS REMOVED, AND PT KNOWING FROM WHAT WAS PROMISED IN THE PREOP LITERATURE THAT NOTHING WOULD BE CUT OR CHANGED, AND KNOWING THEY HAD GOOD RESULTS FROM SYNOVIA SHOTS, REQUESTED TO REMOVE UNISPACER AND THERE WAS NOT A MOVEMENT WITHOUT PAIN, EVEN WITH THE LARGE DOSES OF NARCOTICS, AND PT EXPECTED TO RESUME SYNOVIAL SHOTS. PT THEN LEARNED THAT DUE TO FACTORY REP'S DECISION TO REPLACE THE FIRST UNISPACER AND CUT AND FORCE LAST UNISPACER INTO POSITION, THAT ONLY A TOTAL KNEE TRANSPLANT COULD BE DONE. UNISPACER WAS INSPECTED AND BOTTOM OF UNISPACER WAS NOT SMOOTH BUT HAD 1/2MM GROOVES ON IT. PHYSICIAN HAD UNISPACER, SAID DR SENT IT IN AND COULD NOT FIND IT, EVEN THOUGH THIS WAS DR'S FIRST UNISPACER. ALSO PATHOLOGY REPORTS DID NOT REPORT ANY FLUIDS FROM METAL REJECTION WHICH PT FOUND OUT THERE WAS ONE PERCENT OR MORE IN THE UNISPACER AFTER INSERTION AND THERE COULD POSSIBLY BE A PROBLEM WITH THE METAL, THE MAIN SOURCES OF FLUID WERE SYNOVIAL, OTHERS AND LOSS OF 6 UNITS OF BLOOD WHEN FULL KNEE REPLACEMENT HAD TO TAKE PLACE. FAULT OF SPEC FROM FACTORY. SEVERE GROIN PAIN, HIP PAIN, LOSS OF BALANCE AND OVERALL INSTABILITY. WALKING TROUBLE, HAS BEEN INJURED BY A SULZER HIP OR KNEE REPLACEMENT, CAUSED THEM SEVERE PAIN AND SUFFERING SURGICALLY IMPLANTED LAST YEAR. FACT THAT THEIR DEFECTIVE PRODUCT IS CRIPPLING THOUSANDS OF INNOCENT VICTIMS. REAL PEOPLE SUFFERED BECAUSE THIS CO PUT THE CO'S NAME AND PROFITABILITY AHEAD OF THE HEALTH AND WELFARE OF THE PEOPLE THEY SERVED. PRODUCT DEFECT. PRODUCT LIABILITY. WHAT SULZER ZIMMER PROMISED 1. UNISPACER KNEE SYSTEM. NO BONE CUTS. NO COMPROMISES. 2. ORTHOPEDIC SURGEON FOR TREATMENT OF A KNEE PROBLEM. 3. UNISPACER REQUIRES ONLY MINIMAL SURGICAL INTERVENTION. FOR THOSE PTS WITH THE PROPER INDICATIONS, SURGEONS CAN INSERT THIS SMALL LIGHTWEIGHT, METALLIC INSERT IN THE KNEE JOINT INSTEAD OF CUTTING THE BONE AND REPLACING THE WHOLE KNEE. 4. RESTORING LIGAMENT TENSION AND NORMAL KNEE ALIGHMENT - AT THE SAME TIME PRESERVING THE PT'S NATURAL BONE. 5. THE UNISPACER IS GEOMETRICALLY DESIGNED TO SELF-CENTER WITHIN THE KNEE AND ACTUALLY MOVE WITH THE KNEE, NOT AGAINST IT. THE UNISPACER ADAPTS TO THE NORMAL MOTION OF EACH INDIVIDUAL'S KNEE. 6. TO TRY AND COMPENSATE FOR THE UNBALANCED JOINT, THE BODY SOMETIMES FORMS SMALL BONY GROWTHS CALLED OSTEOPHYTES. THESE OSTEOPHYTES ARE REMOVED AND THE GAP IS FILLED WITH THE UNISPACER IMPLANT TO REALIGN THE LIGAMENTS AND BALANCE THE JOINT. 7. NO BONE CUTS. NO BONE CEMENT. 8. THE UNISPACER IS INTENDED TO RESTORE ALIGNMENT WITHOUT OSTEOTOMY. IMPROVE STABILITY BY RETENSIONING THE LIGAMENTS. SERVE AS A SELF-CENTERING BEARING THAT ACCOMMODATES THE KINEMATICS OF THE INDIVIDUAL KNEE. 9. POSTERIOR CRUCIATE LIGAMENT STRUCTURES MUST BE INTACT. 10. IT ALSO PROVIDES A SMOOTH SURFACE FOR THE BONES TO GLIDE OVER WHEN CARTILAGE HAS BEEN WORN AWAY BY ARTHRITIS. 11. THE UNISPACER COMES IN A WIDE RANGE OF SIZES TO CONFORM AS CLOSELY AS POSSIBLE TO THE WEIGHT AND SIZE OF EACH PT. 12. WHEN THE TIME COMES FOR A PT TO HAVE TOTAL KNEE REPLACEMENT, THE SURGEON SLIPS THE UNISPACER OUT AND THEN PERFORMS THE KNEE REPLACEMENT. BECAUSE THE UNISPACER DOES NOT REQUIRE BONE CUTS OR USE CEMENT, THE TOTAL KNEE REPLACEMENT PROCEDURE IS NOT COMPROMISED. 13. UNISPACER FORCED INTO POSITION THAN WAS NEEDED, CUTTING BONE, BOTTOM NOT SMOOTH BUT HAD 1/2MM GROVES. PHYSICIAN SAW X-RAY AND SAID IT WAS TOO LARGE.