Description of Event or Problem · 1
INFO HAS BEEN RECEIVED FROM A PHYSICIAN AND FROM MEDICAL RECORDS FORWARDED BY THE MFR REGARDING A 42-YEAR-OLD FEMALE WHO RECEIVED THREE RIGHT KNEE INJECTIONS OF SYNVISC (3/25/1998, 4/2/1998 AND 4/8/1998) IN THE TREATMENT OF OSTEOARTHRITIS. CONCOMITANT THERAPY INCLUDED ELAVIL (AMITRIPTYLINE PAMOATE), LORCET (ACETAMINOPHEN & HYDROCODONE BITARTRATE) AND KETOPROFEN. ADDITIONAL MEDICAL HISTORY INCLUDED A RIGHT KNEE MAQUET PROCEDRE (1988) WITH SUBSEQUENT DEVELOPMENT OF REFLEX SYMPATHETIC DYSTROPHY (1991); ARTHROSCOPIC SURGERY FOR A RIGHT PARTIAL MENISECTOMY; SURGICAL GRAFTING OF THE TIBIAL CREST FROM A PELVIC GRAFT (12/1993); CHRONIC LOW BACK PAIN TREATED WITH STERIOD INJECTIONS IN L1 & L2 AND THE SUBSEQUENT DEVELOPMENT OF OSTEOMYELITIS OF L1-L2. THE PT EXPERIENCED ACUTE INTENSE RIGHT KNEE PAIN AND SWELLING 5 WEEKS FOLLOWING THE THIRD INJECTION. ON 4/29/1998 SHE WAS EVALUATED BY HER PHYSICIAN WHO NOTED SWELLING BUT NO SIGNS OF SYNOVITIS. AN X-RAY WAS PERFORMED AND REVEALED SOME CALCIFICATION AROUND THE MEDIAL COMPARTMENT. HOWEVER, ON 5/1/1998 THE PAIN AND SWELLING HAD INCREASED AND THE PHYSICIAN NOTED SOME REDNESS OVER THE LATERAL PATELLA REINACULUM. AN ARTHROCENTESIS WAS PERFORMED. THE CULTURE AND GRAM STAIN WERE NEGATIVE FOR AN INFECTION. THE PATHOLOGY REPORT INDICATED A "SYNOVIUM REACTION" TO A FOREIGN BODY ("BELIEVED TO BE SYNVISC") WHICH WAS DESCRIBED AS A "GIANT CELL REACTION" (GRANULOMA). DISTRIBUTOR'S COMMENTS: THIS REPORT IS BEING SUBMITTED AT THE DISTRIBUTOR'S REQUEST, AS THEY HAVE RECENTLY DETERMINED THAT THEY HAD A REPORTING RESPONSIBLITY DURING THE TIME PERIOD THAT THIS EVENT OCCURRED. THE MFR HAD AN ESTABLISHED MDR REVIEW AND CLOSEOUT PROCESS IN PLACE, AND THIS WAS FOLLOWED ACCORDING TO THE BUSINESS ARRANGEMENT BETWEEN THE TWO PARTIES. IT WAS NOT DEEMED REPORTABLE ACCORDING TO MDR REGULATIONS. THE MFR HAS INCLUDED THIS CASE IN THE SAFETY SUMMARY OF THE PMA ANNUAL REPORT FOR THIS DEVICE MEDICAL PRODUCT.