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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number 8RSP006F
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Arthralgia (2355); Joint Disorder (2373); Neck Pain (2433); Neck Stiffness (2434); No Code Available (3191)
Event Date 02/09/2019
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment 19-apr-2019. Patient experienced couldn't get around without a walker, could not breathe normally, couldn't bend my knees, muscle grew stiff, especially neck and all muscles around midriff, worst pain is in my neck, hard for me even to stand, still have pain and stiffness in my neck, shoulders, lower back and knees, have no energy/weak, tire very easily, feel bad, do not feel well, concentration is not what it usually is, lower back hurts, balance still isn't excellent, hard time sleeping, joint stiffness and joints extremely painful with synvisc. Based on limited information provided, causal role of suspect product cannot be excluded. Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
 
Event Description
Couldn't get around without a walker [walking difficulty], could not breathe normally [difficulty breathing], couldn't bend my knees [joint range of motion decreased], muscles grew stiff, especially neck and all muscles around midriff [muscle stiffness], worst pain is in my neck [neck pain], hard for me even to stand [difficulty in standing], still have pain and stiffness in my neck, shoulders, lower back and knees [pain], have no energy/weak [loss of energy], tire very easily [tiredness], feel bad [feeling bad], do not feel well [feeling unwell], concentration is not what it usually is [concentration impaired], balance still isn't excellent [balance difficulty], lower back hurt [low back pain], hard time sleeping [difficulty sleeping], joint stiffness [joint stiffness], joints extremely painful [joint pain]. Case narrative: initial information received on 15-apr-2019 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5085161. This case involves a patient of unknown demographics who experienced "couldn't get around without a walker, could not breathe normally, couldn't bend my knees, muscle grew stiff, especially neck and all muscles around midriff, worst pain is in my neck, hard for me even to stand, still have pain and stiffness in my neck, shoulders, lower back and knees, have no energy/weak, tire very easily, feel bad, do not feel well, concentration is not what it usually is, lower back hurts, balance still isn't excellent, hard time sleeping, joint stiffness and joints extremely painful" with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history included thyroid surgery in 1984 and anterior cervical discectomy and fusion in 2016. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included losartan; levothyroxine; diclofenac; atorvastatin; potassium chloride (klor-con); solifenacin succinate (vesicare); allopurinol; metformin hydrochloride; vitamin a; vitamin d; vitamin e; thiamine hydrochloride (vitamin b1 [thiamine hydrochloride]); vitamin b12; chromium picolinate; vaccinium macrocarpon (cranberry extract [vaccinium macrocarpon]); folic acid; allium sativum bulb (garlic extract); apple cider vinegar; calcium; magnesium phosphate, potassium phosphate dibasic, sodium sulfate anhydrous (magnesium compound); chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate); valerian extract (valerian extract), lubrisyn and loratadine (loratadine). On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at 2ml dosage (batch - 8rsp006f, exp 03-jan-2021) (frequency, indication: unknown) in left knee. The patient reported that the other two injections were still in the box. On the same day, within 24 hours of receiving the injection, patient experienced all joints were extremely painful (latency: same day). On (b)(6) 2019, patient experienced couldn't bend my knees (latency: 1 day) to sit/stand, muscles grew stiff, especially neck and all muscles around midriff (latency: 1 day). Further, it felt like as if were breathing out against a reverse iron lung. Patient reported that the lungs and respiratory system were ok but the muscles from below their bust down front, back and sides were so tight they could not breathe normally (latency: 1 day). The patient contacted their physician who advised them to visit the emergency room. The patient reported severe pain and stiffness in all their joints, throughout their back and was unable to bend their knees at all to sit down or get up from a chair. The patient couldn't turn their neck which had a titanium plate, left or right at all due to the joint pain and muscle stiffness. The patient had joint stiffness (latency: 1 day) and reported that the muscles around the large swath of their midriff grew completely stiff and painful. Patient felt as if they were breathing out against an iron lung that was pressing in, however, they could tell that their lungs, bronchial tubes and esophagus were functioning normally and this was due to the stiff muscles around their mid riff that made breathing difficult. The stiffness and pain in the midriff eased up after about 48 hours, the other extreme pain lasted about 6 days and then very gradually began to ease as well for days. The patient reported that couldn't even get up or down from a chair without huge effort and couldn't get around without a walker (latency: 1 day) for the first few weeks. Patient added that even after a month later, still have still have pain and stiffness in my neck, shoulders, lower back and knees (latency: 1 day) and the worst pain is in my neck (latency: 1 day), right shoulder and left knee. The lower back hurts (latency: 1 day) worse in the morning and its hard for me even to stand (latency: 1 day). They tire very easily (latency: 1 day), have no energy (latency: 1 day), do not feel well (latency: 1 day) and feel bad (latency: 1 day). Patient gets exhausted doing tasks that were not tiring before and their concentration is not what it usually is (latency: 1 day). They can not sit, stand or walk for too long and have a hard time sleeping (latency: 1 day). Patient reported that the joint pain kept them from falling asleep and sometimes they can not find a comfortable position for sleeping. The patient attributed this reaction of theirs to hylan g-f 20, sodium hyaluronate to any of the four factors such as allergic reaction to injection, having received a contaminated lot number, due to the similarity between catgut and the injection or that the injection and reactions were unrelated and they just happened at the same time. The patient added that currently, they get around their apartment just fine but their balance still isn't excellent (latency: unknown) and they use the walker whenever they get tired or have to go out. The patient was undergoing chiropractic therapy for their back and was doing way better than the first week and was not as weak as before. They stated that the most serious situation currently was in their neck because their neck muscles were still very stiff. The patient still did not feel well at all. The tight muscles around their midriff were better within 2 days, the bad joint pain was less in 6 days but some joints were still stiff and painful. The patients neck was still painful, stiff and did not turn well, the right shoulder and left knee were still quite painful and stiff and the patient was on disability leave for now. Action taken: unknown. Corrective treatment: walker for couldn't get around without a walker; chiropractic therapy for lower back hurts; not reported for rest. Outcome: not recovered for worst pain is in my neck and still have pain, do not feel well and stiffness in my neck, shoulders, lower back and knees; recovering/resolving for muscles grew stiff, especially neck and all muscles around midriff, have no energy/weak and joints extremely painful; unknown for rest seriousness criterion: disability for couldn't get around without a walker; medically significant for all events a product technical complaint was initiated with global ptc (b)(4) and results were pending for the same.
 
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Brand NameSYNVISC
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 Key8577790
MDR Text Key143986627
Report Number2246315-2019-00135
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 consumer
Type of Report Initial,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/03/2021
Device Lot Number8RSP006F
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: 05/03/2019 Patient Sequence Number: 1
Treatment
ALLOPURINOL (ALLOPURINOL),UNKNOWN; APPLE CIDER VINEGAR (APPLE CIDER VINEGAR),UNKNOWN; ATORVASTATIN (ATORVASTATIN),UNKNOWN; CALCIUM (CALCIUM),UNKNOWN; CHROMIUM PICOLINATE (CHROMIUM PICOLINATE),UNKNOWN; CRANBERRY EXTRACT [VACCINIUM MACROCARPON],UNKNOWN; DICLOFENAC (DICLOFENAC),UNKNOWN; FOLIC ACID (FOLIC ACID),UNKNOWN; GARLIC EXTRACT (ALLIUM SATIVUM BULB),UNKNOWN; GLUCOSAMINE CHONDROITIN SULFATE,UNKNOWN; KLOR-CON (POTASSIUM CHLORIDE),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LORATADIN (LORATADINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MAGNESIUM COMPOUND,UNKNOWN; METFORMIN HYDROCHLORIDE,UNKNOWN; VALERIAN EXTRACT (VALERIAN EXTRACT),UNKNOWN; VESICARE (SOLIFENACIN SUCCINATE),UNKNOWN; VITAMIN A NOS (VITAMIN A NOS),UNKNOWN; VITAMIN B1 [THIAMINE HYDROCHLORIDE],UNKNOWN; VITAMIN B12 [VITAMIN B12 NOS],UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; VITAMIN E NOS (VITAMIN E NOS),UNKNOWN
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