FDA Adverse Event Injury Summary report: N

SYNVISC

MDR report key: 512698 · Received February 20, 2004

Report

Report Number
2246315-2004-00020
Event Type
Injury
Date Received
February 20, 2004
Date of Event
September 27, 2001
Report Date
February 20, 2004
Manufacturer
GENZYME CORPORATION
Product Code
MOZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

LEFT KNEE SYNOVITIS; LEFT KNEE SEPTIC ARTHRITIS; POST-OPERATIVE HEMATOMA; ARTHROFIBROSIS. INFO WAS RECEIVED ON 11/4/2003 FROM A PT (AGE UNKNOWN), WHO RECEIVED A SERIES OF THREE SYNVISC INJECTIONS IN 2001 (EXACT INJECTION DATES NOT PROVIDED). THE PT STATED THAT THEY "DEVELOPED AN INFLAMMATORY REACTION WITH SYNOVITIS, SWELLING, AND EFFUSION, WHICH RESULTED IN PERMANENT INJURIES." AT THE TIME OF THIS REPORT, THE PT'S OUTCOME IS UNKNOWN. ADDITIONAL INFO WAS RECEIVED ON 1/21/2004 FROM THE PHYSICIAN. THIS IS A PT WITH A HISTORY OF LEFT KNEE INJURY AND PREVIOUS MULTIPLE LEFT KNEE SURGERIES WHO SUBSEQUENT TO TREATMENT WITH SYNVISC EXPERIENCED LEFT KNEE SYNOVITIS, LEFT KNEE SEPTIC ARTHRITIS, POST-OPERATIVE HEMATOMA AND ARTHROFIBROSIS. THE PT BEGAN TREATMENT WITH SYNVISC 9 MONTHS LATER AND RECEIVED A TOTAL OF THREE INJECTIONS (ONE SERIES) IN THE LEFT KNEE. THE PT RECEIVED A COURSE OF THREE SYNVISC INJECTIONS IN 2001. THEY DID VERY WELL AFTER THE FIRST AND SECOND INJECTIONS AND IMPROVEMENT WAS NOTED IN THE TARGET KNEE. FOLLOWING THE THIRD SYNVISC INJECTION THE PT DEVELOPED SORENESS AND SWELLING IN THE KNEE. NO FEVER, SWEATS, OR CHILLS WERE NOTED. THE PHYSICIAN RECOMMENDED TREATMENT WITH VIOXX AND THAT ICE SHOULD BE APPLIED TO THE LEFT KNEE. TWO DAYS LATER, THE PT WAS SEEN BY THEIR PHYSICIAN AND PHYSICAL EXAMINATION REVEALED NO SIGNS OF INFECTION, AND AN EFFUSION OF +2 +3 WAS NOTED. THE KNEE WAS ASPIRATED FOR 60CC OF MINIMALLY TURBID YELLOW NON-PURULENT FLUID. A CORTICOSTEROID (KENALOG) AND LIDOCAINE WERE ADMINISTERED INTRA-ARTICULARLY AND A SUBSEQUENT IMPROVEMENT IN THE PT'S SYMPTOMS WAS NOTED. THE PHYSICIAN'S ASSESSEMENT WAS: LEFT KNEE SYNOVITIS, NONINFECTIOUS CLINICALLY, STATUS POST SYNVISC INJECTION SERIES. THE FOLLOWING MONTH, THE PT PRESENTED TO THE PHYSICIAN WITH SYMPTOMS OF DISCOMFORT. PHYSICAL EXAM REVEALED A +2+3 EFFUSION AND THE KNEE WAS ASPIRATED FOR 40CC SEROUS SANGUINOUS FLUID. NO EVIDENCE OF INFECTION CLINICALLY WAS NOTED AT THAT TIME. THE PT CONTINUED EXPERIENCING RECURRENT SWELLING. NO FEVER, SWEATS, OR CHILLS. THE PT SUBSEQUENTLY PRESENTED WITH RECURRENT EFFUSIONS AND ARTHROCENTESIS WITH ASPIRATIONS PERFORMED 18 DAYS LATER (60CC OF YELLOW CLEAR FLUID WAS ASPIRATED). THE FOLLOWING DAY (40CC OF SEROUS SANGUINOUS, NON-PURULENT FLUID WAS ASPIRATED AND SENT FOR ANALYSIS), 2 DAYS LATER (40CC OF SEROUS SANGUINOUS, NON-PURULENT FLUID WAS ASPIRATED), 3 DAYS LATAER (100C OF SEROUS SANGUINOUS, NON-PURULENT FLUID WAS RECEIVED AND SENT FOR ANALYSIS), AND THE FOLLOWING DAY (60CC OF SANGUINOUS FLUID WAS ASPIRATED AND SENT FOR ANALYSIS). LAB RESULTS FROM ASPIRATION FLUID OBTAINED SHOWED WBC 33,000 WITH 75 POLYS (UNITS NOT PROVIDED). THE PHYSICIAN STATED THAT THIS WAS CLEARLY AN INFLAMMATORY REACTION OF THE KNEE AND THAT THE POSSIBILITY OF AN OCCULT INFECTION COULD NOT BE TOTALLY EXCLUDED. THE PHYSICIAN SUGGESTED ARTHROSCOPIC IRRIGATION AND SYNOVECTOMY DUE TO THE PERSISTENT PROBLEMS THE PT HAD EXPERIENCED. THE FOLLOWING DAY, THE PT UNDERWENT ARTHROSCOPIC IRRIGATION, DEBRIDEMENT AND SYNOVECTOMY AND BEGAN TREATMENT WITH INTRAVENOUS ROCEPHIN. FIVE DAYS LATER, THE PT PRESENTED WITH A LARGE EFFUSION AND REFUSED ASPIRATION. TWO DAYS LATER, THE PT PRESENTED WITH AN EFFUSION AND GENERALIZED TIGHTNESS. THE KNEE WAS ASPIRATED FOR 30CC OF BLOODY FLUID (DID NOT APPEAR TO BE PURULENT). THE TREAMENT WITH INTRAVENOUS ROCEPHIN WAS CONTINUED. SEVEN DAYS LATER, THE PHYSICIAN STATED THAT THE SYMPTOMS HAVE REMAINED ESSENTIALLY UNCHANGED. PHYSICAL EXAMINATION REVEALED +2+3 EFFUSION. THE PT WAS AFEBRILE. CULTURE RESULTS FROM THE SAMPLE TAKEN SHOWED "MINIMAL STAPHYLOCOCCAL SPECIES COAGULASE NEGATIVE VERY MINIMAL." THE KNEE WAS ASPIRATED FOR 40CC OF SERO-SANGUINOUS FLUID AND SENT FOR ANALYSIS. THE PT WAS DIAGNOSED WITH LEFT KNEE SEPTIC ARTHRITIS, WITH APPARENT COAGULASE NEGATIVE STAPHYLOCOCCUS. HISTORY OF AN INFLAMMATORY REACTION TO SYNVISC TREATMENT WITH MULTIPLE SUBSEQUENT ASPIRATIONS PRIOR TO DEVELOPING THE FORMER WAS NOTED. THE PHYSICIAN ALSO NOTED THAT THE PT WAS STATUS POST-ARTHROSCOPIC SURGERY FOR SYNOVECTOMY I&D (2001). DESPITE TREATMENT WITH RIGOROUS ANTIBIOTICS THE SYMPTOMS PERSISTED, NO DEFINITE EVIDENCE OF A CONTINUING INFECTION. NINE DAYS LATER, THE PT PRESENTED TO THE PHYSICIAN AND PHYSICAL EXAM, OF THE LEFT KNEE REVEALED POSITIVE SWELLING AND MINIMAL CLEAR SEROUS FLUID DRAINAGE FROM THE INFERIOR MEDIAL PORTAL. LEFT KNEE ASSESSEMENT WAS SAME AS PREVIOUS VISIT. DISCUSSION WITH THE PT INCLUDED AN EXPLANATION "ABOUT THEIR PROBLEM WITH CHONDROMMALACIA AND EARLY ARTHRITIS." SEVEN DAYS LATER, THE PT CONTINUED TO COMPLAIN OF PAIN IN THEIR KNEE WITH ACTIVITY AND ALSO AT REST, WITH NO FEVER, SWEATS, OR CHILLS NOTED. THE PT'S CHIEF COMPLAINT WAS STIFFNESS AND SORENESS IN THE KNEE. THEY NOTED SOME IMPROVEMENT AFTER ARTHROSCOPY, BUT CONTINUED TO EXPERIENCE STIFFNESS AND TIGHTNESS WITH ACHING AND BURNING SENSATION. PT INDICATED THEY WERE AMBULATING WITHOUT ASSISTIVE DEVICES. PHYSICAL EXAM REVEALED A FIRM SWELLING IN THE SUPRAPATELLAR AREA WITH TRACE EFFUSION. THE PHYSICIAN'S ASSESSMENT WAS: FIBROSIS OF THE SUPRAPATELLAR AREA FROM THE POST-OPERATIVE HEMATOMA. THE PHYSICIAN NOTES "IT APPEARS THAT THE REACTION FROM THE SYNVISC HAS CALMED DOWN." THE PT CONTINUED TREATMENT WITH ANTIBIOTICS. FIVE DAYS LATER, THE PT NOTED THAT MOTION AND SORENESS IMPROVED, THEY WERE AMBULATING WITHOUT ASSISTIVE DEVICES. PHYSICAL EXAMINATION REVEALED A SLIGHT, TRACE EFFUSION WITH A FIRM, APPARENT CLOT IN THE SUPRA-PATELLAR POUCH AREA, WHICH MADE THE KNEE APPEAR SWOLLEN. THE FOLLOWING MONTH, THE PT CONTINUED TO EXPERIENCE STIFFNESS AND SORENESS, AND TRACE EFFUSION. THEY WERE AFEBRILE AND AMBULATING WITHOUT ASSISTIVE DEVICES AND HAD REGAINED MOTION BACK. THE PHYSICIAN'S ASSESSMENT WAS: RESIDUAL STIFFNESS FROM ARTHROFIBROSIS, SCAR-TISSUE FROM ALL OF THE KNEE SURGERIES. THE PT WAS SEEN FOUR TIMES. THE PHYSICIAN STATED THAT THE PT'S LEFT KNEE AS PREVIOUSLY. THEY CONTINUED TO IMPROVE. THE PT'S WORK STATUS IS FULL DUTY. (MORE)

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA UNK

Patients

Seq Age Sex Outcome Treatment
1 53 YR Hospitalization| R