FDA Adverse Event Other Summary report: N

SYNVISC ONE (HYLAN G-F 20) INJECTION 6ML

MDR report key: 1352236 · Received March 25, 2009

Report

Report Number
2246315-2009-00045
Event Type
Other
Date Received
March 25, 2009
Date of Event
March 10, 2009
Report Date
March 16, 2009
Manufacturer
GENZYME BIOSURGERY (RIDGEFIELD)
Product Code
MOZ
PMA / PMN Number
P940015
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

KNEE HYPERTHERMIA [JOINT WARMTH], IRRITATED KNEE [MUSCULOSKELETAL DISCOMFORT], SWOLLEN KNEE (LEFT) [JOINT SWELLING], REACTIVE JOINT EFFUSION [JOINT EFFUSION], KNEE PAIN (LEFT) [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A PHYSICIAN, VIA A COMPANY REPRESENTATIVE, REGARDING A MALE PATIENT (AGE, INITIALS AND RELEVANT MEDICAL HISTORY NOT PROVIDED). ON (B)(6) 2009, THE PATIENT RECEIVED SYNVISC ONE IN THE KNEE(S) AT A DOES OF 6 ML ONCE ADMINISTERED VIA INTRA-ARTICULAR ROUTE. ON (B)(6) 2009, THE PATIENT EXPERIENCED SWELLING AND PAIN THE LEFT KNEE. THE ADVERSE EVENTS WERE UNKNOWN IN INTENSITY. THE PATIENT WAS TREATED WITH UNNA'S PASTE DRESSING FOR DECLINING THE SYMPTOMS. NO CONCOMITANT MEDICATIONS WERE REPORTED. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PATIENT'S OUTCOME WAS UNKNOWN. THE RELATIONSHIP BETWEEN THE EVENTS OF KNEE SWELLING AND KNEE PAIN AND SYNVISC ONE THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2009, FROM THE TREATING PHYSICIAN REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6). THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES GRADE 3 GONARTHROSIS OF VARUS, KNEE ARTHROSIS, LEFT KNEE PAIN, WIBERG GRADE 3 PATELLA WITH LATERAL CHONDRAL LESION OF THE TROCHLEA, CHONDRAL LESION OF THE PATELLA, MEDIAL SUBCHONDRAL THICKENING OF THE SPONGIOSA IN THE TIBIA AND GRADE 2 MARGINAL BULGING OF THE FEMUR. ON (B)(6) 2009, THE PATIENT RECEIVED SYNVISC ONE INJECTIONS IN EACH KNEE. ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN, ACUTE IRRITATION, SWELLING, REACTIVE EFFUSION AND HYPERTHERMIA IN THE LEFT KNEE. THE CLINICAL EXAMINATION ON (B)(6) 2009, SHOWED NORMAL MOBILITY OF BOTH KNEES. BOTH KNEES LIGAMENTS WERE 150/0/0 AND THE LIGAMENT SUPPORT STABLE. RETROPATELLAR FRICTION WAS FOUND. THE BALLOTTEMENT OF THE PATELLA WAS POSITIVE. THERE WAS NO SIGN OF MENISCUS PROBLEMS. THE PHYSICIAN GAVE THE FOLLOWING DIAGNOSIS: STATUS POST CRUCIATE LIGAMENT PLASTY, GRADE 3 VARUS GONARTHROSIS WITH TIBIAL ROLLING DEFECT, KNEE TROCHLEAR ARTHROSIS, PATELLAR CHONDROPATHY WITH PATELLAR DYSPLASIA AND RIB FRACTURE. ON AN UNKNOWN DATE THE PATIENT RECEIVED TREATMENT WITH 8 MG DEXAHEXAL (DEXAMETHASONE PHOSPHATE), DYNASTAT (PARECOXIB SODIUM) AND RINGER'S SOLUTION (SODIUM AND CHLORIDE). THE PATIENT FOLLOWED THE ACUPUNCTURE THERAPY AND RECEIVED TREATMENT WITH KATADOLON S LONG (FLUPIRTINE MALEATE) AND TETRA-SAAR (50 MG, TETRAZEPAM) AT THE ORTHOPEDICS CENTRE. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT HAD RECOVERED. THE PHYSICIAN ASSESSED THE INTENSITY AS MODERATE AND THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND SYNVISC ONE THERAPY AS PROBABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNVISC ONE (HYLAN G-F 20) INJECTION 6ML VISCOSUPPLEMENT MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention