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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Edema (1820); Erythema (1840); Nausea (1970); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 01/15/2012
Event Type  Injury  
Event Description
Abdominal pain [abdominal pain], vomiting [vomiting], weakness [weakness], range of motion was reduced because of pain and swelling/reduced to about 150 degrees of flexion/reduced to about 140 degrees of flexion [joint range of motion decreased], leukocytosis/white blood count elevated [leukocytosis], hyponatremia [hyponatremia], elevated westergren erythrocyte sedimentation rate and c-reactive protein [erythrocyte sedimentation rate increased], elevated westergren erythrocyte sedimentation rate and c-reactive protein [c-reactive protein increased], altered mental status-she was very drowsy and unable to carry on a clear conversation [mental status changes] ([disorganised speech], [confused], [drowsiness]) unable to bear any weight on left knee [weight bearing difficulty], synovial fluid culture gram stain showed moderate neutrophils [synovial fluid neutrophils present], redness, swelling and pain in the left wrist [localised erythema], redness, swelling and pain in the left wrist [wrist pain], redness, swelling and pain in the left wrist [swelling of wrists], bruising on posterior left knee [contusion of knee], skin biopsies showed palisaded neutrophilic and granulomatous dermatitis [palisaded neutrophilic granulomatous dermatitis] ([skin lesion], [skin nodule]), painful lesion on the inside of her upper lip/ulcer on lip [lip ulcer] ([lip pain]), tolerate diet [food intolerance], dizziness [dizziness], nausea [nausea], ambulate on her own [gait disturbance], edema in both legs [edema legs], radiograph of left knee revealed a large joint effusion [effusion (l) knee] ([swelling of l knee], [aching (l) knee]), case narrative: initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from health care professional via health authorities of united states under reference mw5097905. This case involves an unknown age female patient who experienced abdominal pain, nausea, vomiting, weakness, dizziness, range of motion was reduced because of pain and swelling/reduced to about 150 degrees of flexion/reduced to about 140 degrees of flexion, radiograph of left knee revealed a large joint effusion, leukocytosis/white blood count elevated, hyponatremia, elevated westergren erythrocyte sedimentation rate and c-reactive protein, altered mental status-she was very drowsy and unable to carry on a clear conversation, unable to bear any weight on left knee, synovial fluid culture gram stain showed moderate neutrophils, redness, swelling and pain in the left wrist, bruising on posterior left knee, edema in both legs, skin biopsies showed palisaded neutrophilic and granulomatous dermatitis, painful lesion on the inside of her upper lip/ulcer on lip, ambulate on her own and tolerate diet, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient was previously healthy. Concomitant medications included ethinylestradiol, norethisterone acetate (jinteli); alprazolam; brimonidine; citalopram; sumatriptan for migraine; timolol hemihydrate; methylprednisolone; and prednisone. On (b)(6) 2012, the patient started using intra-articular injection of hylan g-f 20, sodium hyaluronate (strength: 48mg/6ml) once in left knee (lot, indication: unknown). There will be no information available on the batch number for this case. On an unknown date in (b)(6) 2012, patient presented to a local ed (emergency department) complaining of left knee swelling (joint swelling) and pain (arthralgia) along with abdominal pain, nausea, vomiting, weakness (asthenia), and dizziness which began around (b)(6) 2012 (latency: 4 days). Patient noticed some "bumps" on her back at the base of her neck (skin mass) on unknown date in (b)(6) 2012. In ed patient's vital signs were stable and unremarkable, her left knee was swollen tender and non-erythematous, range of motion was reduced because of pain and swelling (joint range of motion decreased, onset: (b)(6) 2012, latency: unknown), she was neurovascularly intact distal to the left knee. On an unknown date in (b)(6) 2012, after unknown latency, patient had three non-pruritic papulonodular lesions present at base of neck (skin lesion), patient was alert and oriented to person, place time and situation radiographs of the left knee revealed a large joint effusion (joint effusion, onset: (b)(6) 2012, latency: few days). Patient had leukocytosis, hyponatremia, and an elevated westergren erythrocyte sedimentation rate (red blood cell sedimentation rate increased) and c-reactive protein (c-reactive protein increased) (onset: (b)(6) 2012, latency: few days). Urinalysis suggested infection and was sent for culture. Ortho was consulted and septic arthritis of left knee was suspected the patient was admitted to the hospital. Left knee was aspirated and the joint fluid analysis was unremarkable and a sample was sent for culture, arthroscopy was performed in the evening with irrigation, debridement and extensive synovectomy and cefazolin was started prior to procedure. On an unknown date in (b)(6) 2012, after latency of few days, patient had altered mental status (mental status changes): she was very drowsy (somnolence) and was unable to carry on a clear conversation (disorganised speech). The patient's hyponatremia was treated with iv (intravenous) normal saline. It was reported that white blood cell count was still elevated but trending downward and one of the nodular lesions on the patient's upper back was punctured and a sample of the fluid was sent for culture. Another urinalysis was suggestive of infection and was sent for culture. It was again noted on an unknown date in (b)(6) 2012, that the patient's mental status was altered, she tended to repeat herself and would stop speaking mid-sentence. Patient's left knee was only slightly swollen with no erythema but was still painful and patient was unable to bear any weight on it (weight bearing difficulty, onset: (b)(4) 2012, latency: few days). More skin nodules were identified above the left knee, white count continued to decline, but was still elevated and sodium remained low. Initial results for synovial fluid culture came back on and unknown date in (b)(6) 2012 and gram stain showed moderate neutrophils (6-30/hpf) but no organisms (synovial fluid white blood cells positive, onset: (b)(6) 2012, latency: few days). Two blood samples were obtained and sent for culture. Two more urinalysis were performed, and samples sent for culture. The urinalyses were both negative the two prior urine cultures showed no growth to date. The antibiotic was changed from cefazolin to ceftaroline and patient was still confused, continued repetitive speech and blocking. It was reported that range of motion in left knee had improved but was still reduced to about 150 degrees of flexion. Skin nodules continued to appear and now were present on her back, left knee, left arm right temple, and right upper chest (12-15 in total) and two of these nodules were biopsied. All previously obtained cultures remained negative to date (joint fluid, urine, blood, and skin nodule cultures). Another culture was taken from a skin nodule on the patient's right temple. On an unknown date in (b)(6) 2012, the patient was much less confused (confusional state, onset: (b)(6) 2012, latency: few days), but still displayed some repetitive speech and blocking. Patient noted a painful lesion on the inside of her upper lip (lip ulceration and lip pain) and also complained of redness, swelling, and pain in the left wrist (erythema, joint swelling, arthralgia) (onset: (b)(6) 2012, latency: few days). Also there was swelling and bruising on the posterior left knee (contusion) and edema in both legs (oedema peripheral) (onset: (b)(6) 2012, latency: few days). The range of motion of left knee reduced at around 140 degrees of flexion. All cultures remained negative and the skin biopsies showed palisaded neutrophilic and granulomatous dermatitis (palisaded neutrophilic granulomatous dermatitis, onset: (b)(6) 2012, latency: few days). Herpes viral antigen tested from ulcer on lip. White count continued a downward trend, and sodium began correcting on its own. Patient was given 125mg of methylprednisolone iv. On an unknown date, patient was no longer confused and abdominal pain and nausea were gone. Swelling in left knee had dissipated, left wrist swelling and pain had decreased and in addition the skin nodules had begun to improve. It was reported that patient began to tolerate diet (food intolerance, onset: (b)(6) 2012, latency: few days) and to ambulate on her own (gait disturbance, onset: (b)(6) 2012, latency: few days). Patient received another dose of 125mg methylprednisolone iv and patient received 120mg of prednisone twice on unknown dates in (b)(6) 2012. The patient continued to improve and was discharged to home on an unknown date in (b)(6) 2012. All events were assessed as serious (criteria: life threatening and hospitalization for all events and also intervention required for joint effusion). Action taken: not applicable for all events corrective treatment: normal saline for hyponatraemia, arthroscopy with irrigation, debridement extensive synovectomy, cefazolin and ceftaroline for joint effusion, not reported for rest of the events outcome: recovered for abdominal pain, nausea, confusional state, gait disturbance, food intolerance, joint swelling (knee swelling), not recovered for arthralgia (knee pain), mental status change, recovering for joint range of motion decreased, skin lesion, leukocytosis, hyponatremia, skin mass, erythema, joint swelling, arthralgia (swelling and pain in the left wrist), unknown for rest of the events a product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one for unknown batch number and global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr (non-conformances report) process. Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required. Investigation completion date: (b)(6) 2020. Additional information was received on (b)(6) 2020 from healthcare professional. Investigational results were added. Text amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key11075644
MDR Text Key229812522
Report Number2246315-2020-00181
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2020 Patient Sequence Number: 1
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