SYNVISC ONE
Report
- Report Number
- 2246315-2019-00026
- Event Type
- Injury
- Date Received
- January 23, 2019
- Report Date
- March 28, 2019
- Manufacturer
- GENZYME CORPORATION(RIDGEFIELD)
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
SANOFI COMPANY COMMENT FOR FOLLOW UP DATED (B)(6) 2019. THE FOLLOW UP INFORMATION DOES NOT CHANGE THE PREVIOUS ASSESSMENT OF THE CASE. THIS CASE CONCERNS A MALE ADULT PATIENT HAD INABILITY TO BEAR WEIGHT AND INTERNAL DERANGEMENT OF LEFT KNEE. BASED ON THE AVAILABLE INFORMATION, PHARMACOLOGICAL PLAUSIBILITY CAN BE ESTABLISHED BETWEEN THE EVENT AND SUSPECT PRODUCT. HOWEVER, MORE INFORMATION REGARDING PATIENT'S CONCURRENT CLINICAL PRESENTATION, RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS IS REQUIRED FOR FURTHER CASE ASSESSMENT.
SANOFI COMPANY COMMENT FOR FOLLOW UP DATED (B)(6) 2019. THE FOLLOW UP INFORMATION DOES NOT CHANGE THE PREVIOUS ASSESSMENT OF THE CASE. THIS CASE CONCERNS A MALE ADULT PATIENT HAD INABILITY TO BEAR WEIGHT AND INTERNAL DERANGEMENT OF LEFT KNEE. BASED ON THE AVAILABLE INFORMATION, PHARMACOLOGICAL PLAUSIBILITY CAN BE ESTABLISHED BETWEEN THE EVENT AND SUSPECT PRODUCT. HOWEVER, MORE INFORMATION REGARDING PATIENT'S CONCURRENT CLINICAL PRESENTATION, RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS IS REQUIRED FOR FURTHER CASE ASSESSMENT.
INTERNAL DERANGEMENT OF LEFT KNEE [INTERNAL DERANGEMENT OF KNEE] INABILITY TO BEAR WEIGHT [WEIGHT BEARING DIFFICULTY] SWELLING LEFT KNEE [KNEE SWELLING] LOT OF PAIN IN LEFT KNEE/ JOINT PAIN [KNEE PAIN] RIGHT KNEE EFFUSION [KNEE EFFUSION] CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE. [JOINT CREPITATION] INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT [SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT] GOUT ATTACK [GOUT ATTACK] . CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 14-JAN-2019 REGARDING AN UNSOLICITED LEGAL VALID SERIOUS CASE RECEIVED FROM A NON-HEALTHCARE PORFESSIONAL. THIS CASE INVOLVES A 54 YEARS OLD MALE PATIENT WHO EXPERIENCED INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT AND GOUT ATTACK, WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC ONE). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, ARTHRALGIA, JOINT DISLOCATION, PATELLOFEMORAL PAIN SYNDROME, KNEE DEFORMITY, HIP ARTHROPLASTY IN 2010, MENISCUS REMOVAL IN 2010, JOINT SWELLING, CHOLECYSTECTOMY, LEFT ELBOW SURGERY IN 2013, KNEE ARTHROPLASTY IN DEC-2010 AND SHOULDER OPERATION. THE PATIENT'S PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING TYPE 2 DIABETES MELLITUS, HYPERTENSION ON (B)(6) 2012 OBESITY ON (B)(6) 2012 , HYPERLIPIDAEMIA, PROTEINURIA ON (B)(6) 2012 , TENDON RUPTURE ON (B)(6) 2014, LARGE INTESTINE POLYP ON (B)(6) 2015AND DRUG HYPERSENSITIVITY. CONCOMITANT MEDICATIONS INCLUDED SODIUM BICARBONATE; NIFEDIPINE; LOSARTAN POTASSIUM (COZAAR); GLIPIZIDE (GLIPIZIDE XL); FLUTICASONE PROPIONATE; CYCLOBENZAPRINE HYDROCHLORIDE; ALLOPURINOL (ZYLOPRIM); ATORVASTATIN CALCIUM (LIPITOR); LIDOCAINE HCL; AND TRAMADOL HYDROCHLORIDE (ULTRAME). ON(B)(6) 2017, THE PATIENT STARTED TAKING SYNVISC ONE (HYLAN G-F 20, SODIUM HYALURONATE), INJECTION DOSE- 48 MG VIA INTRA-ARTICULAR (WITH AN UNKNOWN BATCH NUMBER) FOR PRIMARY OSTEOARTHRITIS OF LEFT KNEE. ON AN UNKNOWN DATE, THE PATIENT HAD INTERNAL DERANGEMENT OF LEFT KNEE (JOINT DISLOCATION), CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE (CREPITATIONS), GOUT ATTACK (GOUT) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT VISITED THE CLINIC AND REPORTED THAT ON (B)(6) 2017, THE PATIENT DEVELOPED AN INABILITY TO BEAR WEIGHT (WEIGHT BEARING DIFFICULTY), SWELLING LEFT KNEE (JOINT SWELLING), LOT OF PAIN IN LEFT KNEE/ JOINT PAIN (ARTHRALGIA) 2 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017 THE PATIENT DEVELOPED A SERIOUS RIGHT KNEE EFFUSION (JOINT EFFUSION) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT HAD INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT (SYNOVIAL FLUID CRYSTAL PRESENT) 8 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE PATIENT REPORTED THAT THE PAIN STARTED 2 SEVERE 10/10 PAIN STARTING 2 DAYS FOLLOWING INJECTION. PAIN WAS SEVERE AT NIGHT. ON 27-NOV-2017, THE PATIENT HAD 76CC'S OF NORMAL JOINT FLUID ASPIRATED FROM THE LEFT KNEE JOINT USING A 22G X 1.5 NEEDLE IN STERILE FASHION WITHOUT COMPLICATION. FOLLOWING ASPIRATION, A DIAGNOSTIC AND THERAPEUTIC INJECTION OF 1CC KENALOG WAS GIVEN UNDER STERILE TECHNIQUE USING A 22G X 1.5 NEEDLE INTO THE LEFT KNEE JOINT IN SEATED POSITION. THE PATIENT HAD NO ADVERSE REACTIONS TO THE MEDICATION. PAIN DECREASED. THE PATIENT WAS INSTRUCTED TO APPLY ICE TO THE JOINT FOR 20 MINUTES AND AVOID STRENUOUS ACTIVITIES FOR 24-36 HOURS FOLLOWING THE INJECTION. JOINT FLUID SENT TO THE LAB FOR ANALYSIS: INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - ON (B)(6) 2017 [76CC'S OF NORMAL JOINT FLUID WAS ASPIRATED FROM THE LEFT KNEE JOINT]. BACTERIAL TEST - ON 28-NOV-2017: [NO GROWTH] GRAM STAIN - ON 28-NOV-2017: [FEW WBC IN JOINT FLUID] SYNOVIAL FLUID CRYSTAL PRESENT - ON 28-NOV-2017: SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT UNK FINAL DIAGNOSIS WAS SEVERE LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE. THE PATIENT WAS TREATED WITH TRIAMCINOLONE ACETONIDE (KENALOG) FOR INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION. OUTCOME- UNKNOWN FOR ALL EVENTS A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED ON 17-JAN-2019 FOR SYNVISC ONE. BATCH NUMBER: UNKNOWN; GLOBAL PTC NUMBER: 56990. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERIA- INTERVENTION REQUIRED FOR SEVERE LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-JAN-2019. GLOBAL PTC NUMBER AND ITS RESULTS WERE ADDED. TEXT AMENDED ACCORDINGLY.
INTERNAL DERANGEMENT OF LEFT KNEE [INTERNAL DERANGEMENT OF KNEE]. INABILITY TO BEAR WEIGHT [WEIGHT BEARING DIFFICULTY] . SWELLING LEFT KNEE [KNEE SWELLING] . LOT OF PAIN IN LEFT KNEE/ JOINT PAIN [KNEE PAIN] . RIGHT KNEE EFFUSION/FLUID IN KNEE [KNEE EFFUSION]. CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE. [JOINT CREPITATION]. INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT [SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT] . GOUT ATTACK [GOUT ATTACK] . CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 14-JAN-2019 REGARDING AN UNSOLICITED LEGAL VALID SERIOUS CASE RECEIVED FROM A NON-HEALTHCARE PORFESSIONAL. THIS CASE INVOLVES A 54 YEARS OLD MALE PATIENT WHO EXPERIENCED INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION/FLUID IN KNEE, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT AND GOUT ATTACK, WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC ONE). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, ARTHRALGIA, JOINT DISLOCATION, PATELLOFEMORAL PAIN SYNDROME, KNEE DEFORMITY, HIP ARTHROPLASTY IN 2010, MENISCUS REMOVAL IN 2010, JOINT SWELLING, CHOLECYSTECTOMY, LEFT ELBOW SURGERY IN 2013, KNEE ARTHROPLASTY IN (B)(6) 2010 AND SHOULDER OPERATION. THE PATIENT'S PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING TYPE 2 DIABETES MELLITUS, HYPERTENSION ON (B)(6) 2012, OBESITY ON (B)(6) 2012, HYPERLIPIDAEMIA, PROTEINURIA ON (B)(6) 2012, TENDON RUPTURE ON (B)(6) 2014, LARGE INTESTINE POLYP ON (B)(6) 2015 AND DRUG HYPERSENSITIVITY. CONCOMITANT MEDICATIONS INCLUDED SODIUM BICARBONATE; NIFEDIPINE; LOSARTAN POTASSIUM (COZAAR); GLIPIZIDE (GLIPIZIDE XL); FLUTICASONE PROPIONATE; CYCLOBENZAPRINE HYDROCHLORIDE; ALLOPURINOL (ZYLOPRIM); ATORVASTATIN CALCIUM (LIPITOR); LIDOCAINE HCL; AND TRAMADOL HYDROCHLORIDE (ULTRAME). ON (B)(6) 2017, THE PATIENT STARTED TAKING SYNVISC ONE (HYLAN G-F 20, SODIUM HYALURONATE), INJECTION DOSE- 48 MG VIA INTRA-ARTICULAR (WITH AN UNKNOWN BATCH NUMBER) FOR PRIMARY OSTEOARTHRITIS OF LEFT KNEE. ON AN UNKNOWN DATE, THE PATIENT HAD INTERNAL DERANGEMENT OF LEFT KNEE (JOINT DISLOCATION), CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE (CREPITATIONS), GOUT ATTACK (GOUT) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON(B)(6) 2017, THE PATIENT VISITED THE CLINIC AND REPORTED THAT ON(B)(6) 2017, THE PATIENT DEVELOPED AN INABILITY TO BEAR WEIGHT (WEIGHT BEARING DIFFICULTY), SWELLING LEFT KNEE (JOINT SWELLING), LOT OF PAIN IN LEFT KNEE/ JOINT PAIN (ARTHRALGIA) 2 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT DEVELOPED A SERIOUS RIGHT KNEE EFFUSION (JOINT EFFUSION) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT HAD INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT (SYNOVIAL FLUID CRYSTAL PRESENT) 8 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE PATIENT REPORTED THAT THE PAIN STARTED 2 SEVERE 10/10 PAIN STARTING 2 DAYS FOLLOWING INJECTION. PAIN WAS SEVERE AT NIGHT. ON (B)(6) 2017, THE PATIENT HAD 76CC'S OF NORMAL JOINT FLUID ASPIRATED FROM THE LEFT KNEE JOINT USING A 22G X 1.5 NEEDLE IN STERILE FASHION WITHOUT COMPLICATION. FOLLOWING ASPIRATION, A DIAGNOSTIC AND THERAPEUTIC INJECTION OF 1CC KENALOG WAS GIVEN UNDER STERILE TECHNIQUE USING A 22G X 1.5 NEEDLE INTO THE LEFT KNEE JOINT IN SEATED POSITION. THE PATIENT HAD NO ADVERSE REACTIONS TO THE MEDICATION. PAIN DECREASED. THE PATIENT WAS INSTRUCTED TO APPLY ICE TO THE JOINT FOR 20 MINUTES AND AVOID STRENUOUS ACTIVITIES FOR 24-36 HOURS FOLLOWING THE INJECTION. JOINT FLUID SENT TO THE LAB FOR ANALYSIS: INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT. ON (B)(6) 2018, THE PATIENT AGAIN EXPERIENCED KNEE PAIN AND JOINT SWELLING WHICH RECOVERED IN 2 WEEKS. ON AN UNKNOWN DATE, THE PATIENT HAD FLUID IN KNEE AND RECOVERED FROM IT. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - ON (B)(6) 2017: [76CC'S OF NORMAL JOINT FLUID WAS ASPIRATED FROM THE LEFT KNEE JOINT] BACTERIAL TEST - ON (B)(6) 2017: [NO GROWTH] GRAM STAIN - ON (B)(6) 2017: [FEW WBC IN JOINT FLUID] SYNOVIAL FLUID CRYSTAL PRESENT - ON (B)(6) 2017: SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT UNK. FINAL DIAGNOSIS WAS SEVERE LOT OF PAIN IN LEFT KNEE JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION/FLUID IN KNEE, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE. THE PATIENT WAS TREATED WITH TRIAMCINOLONE ACETONIDE (KENALOG) FOR INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION/FLUID IN KNEE. OUTCOME- RECOVERED FROM SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION/FLUID IN KNEE; UNKNOWN FOR REST OF THE EVENTS. A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED ON (B)(6) 2019 FOR SYNVISC ONE. BATCH NUMBER: UNKNOWN; GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERIA- INTERVENTION REQUIRED FOR SEVERE LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION/FLUID IN KNEE, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-JAN-2019. GLOBAL PTC NUMBER AND ITS RESULTS WERE ADDED. TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAR-2019 FROM PATIENT. VERBATIM UPDATED FOR RIGHT KNEE EFFUSION/FLUID KNEE. OUTCOME UPDATED FOR THE EVENT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION/FLUID KNEE, SWELLING LEFT KNEE. CLINICAL COURSE WAS UPDATED AND TEXT AMENDED ACCORDINGLY.
INTERNAL DERANGEMENT OF LEFT KNEE [INTERNAL DERANGEMENT OF KNEE]; INABILITY TO BEAR WEIGHT [WEIGHT BEARING DIFFICULTY]; SWELLING LEFT KNEE [KNEE SWELLING]; LOT OF PAIN IN LEFT KNEE/ JOINT PAIN [KNEE PAIN]; RIGHT KNEE EFFUSION [KNEE EFFUSION]; CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE. [CREPITATIONS]; INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT [SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT]; GOUT ATTACK [GOUT ATTACK]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 14-JAN-2019 REGARDING AN UNSOLICITED LEGAL VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A (B)(6) YEARS OLD MALE PATIENT WHO EXPERIENCED INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT AND GOUT ATTACK, WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC ONE). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS, ARTHRALGIA, JOINT DISLOCATION, PATELLOFEMORAL PAIN SYNDROME, KNEE DEFORMITY, HIP ARTHROPLASTY IN 2010, MENISCUS REMOVAL IN 2010, JOINT SWELLING, CHOLECYSTECTOMY, LEFT ELBOW SURGERY IN 2013, KNEE ARTHROPLASTY IN (B)(6) 2010 AND SHOULDER OPERATION. THE PATIENT'S PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING TYPE 2 DIABETES MELLITUS, HYPERTENSION ON (B)(6) 2012, OBESITY ON (B)(6)2012, HYPERLIPIDAEMIA, PROTEINURIA ON (B)(6) 2012, TENDON RUPTURE ON (B)(6) 2014, LARGE INTESTINE POLYP ON (B)(6) 2015 AND DRUG HYPERSENSITIVITY. CONCOMITANT MEDICATIONS INCLUDED SODIUM BICARBONATE; NIFEDIPINE; LOSARTAN POTASSIUM (COZAAR); GLIPIZIDE (GLIPIZIDE XL); FLUTICASONE PROPIONATE; CYCLOBENZAPRINE HYDROCHLORIDE; ALLOPURINOL (ZYLOPRIM); ATORVASTATIN CALCIUM (LIPITOR); LIDOCAINE HCL; AND TRAMADOL HYDROCHLORIDE (ULTRAME). ON (B)(6) 2017, THE PATIENT STARTED TAKING SYNVISC ONE (HYLAN G-F 20, SODIUM HYALURONATE), INJECTION DOSE- 48 MG VIA INTRA-ARTICULAR (WITH AN UNKNOWN BATCH NUMBER) FOR OSTEOARTHRITIS. ON AN UNKNOWN DATE, THE PATIENT HAD INTERNAL DERANGEMENT OF LEFT KNEE (JOINT DISLOCATION), CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE (CREPITATIONS), GOUT ATTACK (GOUT) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT VISITED THE CLINIC AND REPORTED THAT ON (B)(6) 2017, THE PATIENT DEVELOPED AN INABILITY TO BEAR WEIGHT (WEIGHT BEARING DIFFICULTY), SWELLING LEFT KNEE (JOINT SWELLING), LOT OF PAIN IN LEFT KNEE/ JOINT PAIN (ARTHRALGIA) 2 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT DEVELOPED A SERIOUS RIGHT KNEE EFFUSION (JOINT EFFUSION) FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON (B)(6) 2017, THE PATIENT HAD INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT (SYNOVIAL FLUID CRYSTAL PRESENT) 8 DAYS FOLLOWING THE FIRST DOSE INTAKE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE PATIENT REPORTED THAT THE PAIN STARTED 2 SEVERE 10/10 PAIN STARTING 2 DAYS FOLLOWING INJECTION. PAIN WAS SEVERE AT NIGHT. ON (B)(6) 2017, THE PATIENT HAD 76CC'S OF NORMAL JOINT FLUID ASPIRATED FROM THE LEFT KNEE JOINT USING A 22G X 1.5 NEEDLE IN STERILE FASHION WITHOUT COMPLICATION. FOLLOWING ASPIRATION, A DIAGNOSTIC AND THERAPEUTIC INJECTION OF 1CC KENALOG WAS GIVEN UNDER STERILE TECHNIQUE USING A 22G X 1.5 NEEDLE INTO THE LEFT KNEE JOINT IN SEATED POSITION. THE PATIENT HAD NO ADVERSE REACTIONS TO THE MEDICATION. PAIN DECREASED. THE PATIENT WAS INSTRUCTED TO APPLY ICE TO THE JOINT FOR 20 MINUTES AND AVOID STRENUOUS ACTIVITIES FOR 24-36 HOURS FOLLOWING THE INJECTION. JOINT FLUID SENT TO THE LAB FOR ANALYSIS: INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - ON (B)(6) 2017: [76CC'S OF NORMAL JOINT FLUID WAS ASPIRATED FROM THE LEFT KNEE JOINT]; BACTERIAL TEST - ON (B)(6) 2017: [NO GROWTH]; GRAM STAIN - ON (B)(6) 2017: [FEW WBC IN JOINT FLUID]; SYNOVIAL FLUID CRYSTAL PRESENT - ON (B)(6) 2017: SYNOVIAL FLUID MONOSODIUM URATE CRYSTAL PRESENT UNK. FINAL DIAGNOSIS WAS SEVERE LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE. THE PATIENT WAS TREATED WITH TRIAMCINOLONE ACETONIDE (KENALOG) FOR INTERNAL DERANGEMENT OF LEFT KNEE, INABILITY TO BEAR WEIGHT, SWELLING LEFT KNEE, LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, RIGHT KNEE EFFUSION. OUTCOME- UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERIA- INTERVENTION REQUIRED FOR SEVERE LOT OF PAIN IN LEFT KNEE/ JOINT PAIN, INABILITY TO BEAR WEIGHT, INTRA AND EXTRACELLULAR URATE CRYSTALS PRESENT, GOUT ATTACK, CREPITUS OF THE PATELLA, MFC AND LATERAL JOINT LINE, RIGHT KNEE EFFUSION, SWELLING LEFT KNEE AND INTERNAL DERANGEMENT OF LEFT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64667 | SYNVISC ONE | MOZ | MOZ | GENZYME CORPORATION(RIDGEFIELD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | COZAAR (LOSARTAN POTASSIUM),UNKNOWN| COZAAR (LOSARTAN POTASSIUM),UNKNOWN| COZAAR (LOSARTAN POTASSIUM),UNKNOWN| CYCLOBENZAPRINE [CYCLOBENZAPRINE HYDROCHLORIDE],TA| CYCLOBENZAPRINE [CYCLOBENZAPRINE HYDROCHLORIDE],TA| CYCLOBENZAPRINE [CYCLOBENZAPRINE HYDROCHLORIDE],TA| FLUTICASONE [FLUTICASONE PROPIONATE],UNKNOWN| FLUTICASONE [FLUTICASONE PROPIONATE],UNKNOWN| FLUTICASONE [FLUTICASONE PROPIONATE],UNKNOWN| GLIPIZIDE XL (GLIPIZIDE),TABLET| GLIPIZIDE XL (GLIPIZIDE),TABLET| GLIPIZIDE XL (GLIPIZIDE),TABLET| LIDOCAINE HCL (LIDOCAINE HCL),UNKNOWN| LIDOCAINE HCL (LIDOCAINE HCL),UNKNOWN| LIDOCAINE HCL (LIDOCAINE HCL),UNKNOWN| LIPITOR (ATORVASTATIN CALCIUM),| LIPITOR (ATORVASTATIN CALCIUM),| LIPITOR (ATORVASTATIN CALCIUM),| NIFEDIPINE (II) (NIFEDIPINE),UNKNOWN| NIFEDIPINE (II) (NIFEDIPINE),UNKNOWN| NIFEDIPINE (II) (NIFEDIPINE),UNKNOWN| SODIUM BICARBONATE (SODIUM BICARBONATE),TABLET| SODIUM BICARBONATE (SODIUM BICARBONATE),TABLET| SODIUM BICARBONATE (SODIUM BICARBONATE),TABLET| ULTRAME (TRAMADOL HYDROCHLORIDE),UNKNOWN| ULTRAME (TRAMADOL HYDROCHLORIDE),UNKNOWN| ULTRAME (TRAMADOL HYDROCHLORIDE),UNKNOWN| ZYLOPRIM (ALLOPURINOL),UNKNOWN| ZYLOPRIM (ALLOPURINOL),UNKNOWN| ZYLOPRIM (ALLOPURINOL),UNKNOWN| COZAAR (LOSARTAN POTASSIUM),UNKNOWN| CYCLOBENZAPRINE [CYCLOBENZAPRINE HYDROCHLORIDE],TA| FLUTICASONE [FLUTICASONE PROPIONATE],UNKNOWN| GLIPIZIDE XL (GLIPIZIDE),TABLET| LIDOCAINE HCL (LIDOCAINE HCL),UNKNOWN| LIPITOR (ATORVASTATIN CALCIUM),| NIFEDIPINE (II) (NIFEDIPINE),UNKNOWN| SODIUM BICARBONATE (SODIUM BICARBONATE),TABLET| ULTRAME (TRAMADOL HYDROCHLORIDE),UNKNOWN| ZYLOPRIM (ALLOPURINOL),UNKNOWN |