MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Date 03/01/2016

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on 28-mar-2016 from a patient.This case concerns a (b)(6) female patient who started treatment with synvisc one and later had cellulitis, couldn't walk/severe mobility issue, had the same reaction with identical symptoms excluding the cellulitis, had the same reaction with identical symptoms excluding the cellulitis, chills, nausea, had a low grade temperature, had the same reaction with identical symptoms excluding the cellulitis, had a low grade temperature and horrible sweat.The patient had the synvisc 3 injection several years ago and did not have any type of reaction.It was reported, the patient also had the suprex series of 5 with ultrasound and did not have a reaction.No medical history, concurrent conditions or concomitant medications were reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection, once, at a dose of 6 ml, once (batch/lot number and expiration date: not provided) in her left knee for osteoarthritis.It was reported that the patient became very sick afterward.It was reported that it was awful and the next morning the patient couldn't walk but kept moving and was able to use her cane.It was reported that the patient had severe mobility issue with pain in and around the injection site but not where the needle went in.It was reported that the patient went to the doctor 2 days later and had swelling, cellulitis, chills for days and nausea.As corrective treatment, the patient took cefalexin monohydrate (keflex) at a dose of 500 mg 4 times daily which improved the symptoms.On an unknown date, the patient had the synvisc one injection in the right knee one week later and had the same reaction with identical symptoms excluding the cellulitis.It was reported that her doctor put her back on cefalexin monohydrate and it didn't kick in as well as the first time.Also reported, the patient had a low grade temperature, horrible sweat and the pain was intense.It was reported that after two days, the patient had no pain.Also reported, finally the patient was feeling better and all of her symptoms were all gone now but she still wanted to call in and report the problem.Corrective treatment: cefalexin monohydrate for cellulitis and not reported for rest of the events.Outcome: recovering/resolving for cellulitis, unknown for couldn't walk/severe mobility issue and recovered for rest of the events.A pharmaceutical technical complaint was initiated and results were pending for the same.Seriousness criteria: important medical event for cellulitis.Pharmacovigilance comment: (b)(4) company comment dated 1-apr-2016: this case concerns a patient who received synvisc one injection in her left knee and developed cellulitis at the injection site with the associated symptoms of pain and swelling.As per the information reported there exists a positive temporal relationship between the occurrence of the event and the administration of the product.Also, it has been mentioned that the patient developed same reaction after receiving synvisc one in right knee along with low grade temperature and sweating but did not develop cellulitis.Based upon this information a positive causal relationship can be concluded between the event and the product.However, since there is no information regarding the technique of injection, the conditions under which the patient received the injections and severity of the underlying osteoarthritis, a comprehensive case assessment is difficult.

Event Description

This unsolicited device case from united states was received on 28-mar-2016 from a patient.This case concerns a (b)(6) female patient who started treatment with synvisc one and later had cellulitis, couldn't walk/severe mobility issue, had the same reaction with identical symptoms excluding the cellulitis, had the same reaction with identical symptoms excluding the cellulitis, chills, nausea, had a low grade temperature, had the same reaction with identical symptoms excluding the cellulitis, had a low grade temperature and horrible sweat.The patient had the synvisc 3 injection several years ago and did not have any type of reaction.It was reported, the patient also had the suprex series of 5 with ultrasound and did not have a reaction.No medical history, concurrent conditions or concomitant medications were reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection, once, at a dose of 6 ml, once (batch/lot number and expiration date: not provided) in her left knee for osteoarthritis.It was reported that the patient became very sick afterward.It was reported that it was awful and the next morning the patient couldn't walk but kept moving and was able to use her cane.It was reported that the patient had severe mobility issue with pain in and around the injection site but not where the needle went in.It was reported that the patient went to the doctor 2 days later and had swelling, cellulitis, chills for days and nausea.As corrective treatment, the patient took cefalexin monohydrate (keflex) at a dose of 500 mg 4 times daily which improved the symptoms.On an unknown date, the patient had the synvisc one injection in the right knee one week later and had the same reaction with identical symptoms excluding the cellulitis.It was reported that her doctor put her back on cefalexin monohydrate and it didn't kick in as well as the first time.Also reported, the patient had a low grade temperature, horrible sweat and the pain was intense.It was reported that after two days, the patient had no pain.Also reported, finally the patient was feeling better and all of her symptoms were all gone now but she still wanted to call in and report the problem.Corrective treatment: cefalexin monohydrate for cellulitis and not reported for rest of the events outcome: recovering/resolving for cellulitis, unknown for couldn't walk/severe mobility issue and recovered for rest of the events (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 was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored 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 had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event for cellulitis additional information was received on 06-apr-2016.The ptc results were added and text was amended accordingly.Follow up was received on 07-apr-2016.No new information was received.Pharmacovigilance comment: sanofi company comment for follow up dated 06-apr-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 1-apr-2016: this case concerns a patient who received synvisc one injection in her left knee and developed cellulitis at the injection site with the associated symptoms of pain and swelling.As per the information reported there exists a positive temporal relationship between the occurrence of the event and the administration of the product.Also, it has been mentioned that the patient developed same reaction after receiving synvisc one in right knee along with low grade temperature and sweating but did not develop cellulitis.Based upon this information a positive causal relationship can be concluded between the event and the product.However, since there is no information regarding the technique of injection, the conditions under which the patient received the injections and severity of the underlying osteoarthritis, a comprehensive case assessment is difficult.

Event Description

This unsolicited device case from united states was received on (b)(6) 2016 from a patient.This case concerns a (b)(6) female patient who started treatment with synvisc one and later had cellulitis, discomfort, couldn't walk/severe mobility issue, had the same reaction with identical symptoms excluding the cellulitis, had the same reaction with identical symptoms excluding the cellulitis, chills, nausea, still has the original knee pain (therapeutic response decreased), had a low grade temperature, had the same reaction with identical symptoms excluding the cellulitis, had a low grade temperature and horrible sweat.The medical history included spinal fusion (laminectomy in (b)(6) 2006), right total hip replacement (in (b)(6) 2015), squamous cell removed from ear ((b)(6) 2015), hypertension (controlled), degenerative disc disease in lower back and dry eye.The patient had hyperactivity to pethidine hydrochloride (demerol) (last given in 1969 for delivery).The past drug included clarithromycin (biaxin) (stomach upset).The concomitant medications included: levothyroxine sodium (levothyroxine) as suppression therapy, quinapril, atenolol and amiloride for hypertension, rosuvastatin calcium (crestor) for high cholesterol, escitalopram oxalate (escitalopram), ciclosporin (restasis), fish oil b complex, cholecalciferol (vitamin d-3).The patient had the synvisc 3 injection several years ago and did not have any type of reaction.It was reported, the patient also had the suprex series of 5 with ultrasound and did not have a reaction.No, concurrent conditions were reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection, once, at a dose of 6 ml, once (batch/lot number and expiration date: not provided) in her left knee for osteoarthritis.It was reported that next day, the patient had more pain and swelling.It was reported that the patient became very sick afterward.It was reported that it was awful and the next morning the patient couldn't walk but kept moving and was able to use her cane.It was reported that the patient had severe mobility issue with pain in and around the injection site but not where the needle went in.It was reported that the patient went to the doctor 2 days later and had swelling, chills for days and nausea.On an unknown date in (b)(6) 2016, the patient was diagnosed with cellulitis and reaction-infection.As corrective treatment, the patient took cephalexin monohydrate (keflex) at a dose of 500 mg 2 times daily for 8 days which improved the symptoms.On (b)(6) 2016, the patient consulted a healthcare professional and received synvisc one injection in 1 unspecified knee.On an unknown date in 2016 (2 weeks later), the patient had the synvisc one injection and had pain and discomfort.It was reported that her doctor put her back on cefalexin monohydrate and it didn't kick in as well as the first time.The patient had no cellulitis, had extreme chills and nausea both times.Also reported, the patient had a low grade temperature, horrible sweat and the pain was intense.It was reported that after two days, the patient had no pain.Also reported, finally the patient was feeling better and all of her symptoms were all gone now but she still wanted to call in and report the problem.On (b)(6) 2016, the patient again received synvisc one injection in other knee.On an unknown date, the patient still had the original knee pain (therapeutic response decreased).Corrective treatment: cefalexin monohydrate for cellulitis and not reported for rest of the events outcome: recovered for discomfort, cellulitis, nausea, chills, had a low grade temperature, horrible sweat, had the same reaction with identical symptoms excluding the cellulitis, had the same reaction with identical symptoms excluding the cellulitis; unknown for couldn't walk/severe mobility issue a pharmaceutical technical complaint was initiated with (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 was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored 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 had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event for cellulitis additional information was received on 06-apr-2016.The ptc results were added and text was amended accordingly.Follow up was received on 07-apr-2016.No new information was received.Additional information was received on 09-may-2016 from the patient.The additional events of discomfort and still has the original knee pain (therapeutic response decreased) were added with details.The patient's medical history was added.The past drugs (clarithromycin, pethidine hydrochloride) were added.The concomitant medications were added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 06-apr-2016 and 9-may-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 1-apr-2016: this case concerns a patient who received synvisc one injection in her left knee and developed cellulitis at the injection site with the associated symptoms of pain and swelling.As per the information reported there exists a positive temporal relationship between the occurrence of the event and the administration of the product.Also, it has been mentioned that the patient developed same reaction after receiving synvisc one in right knee along with low grade temperature and sweating but did not develop cellulitis.Based upon this information a positive causal relationship can be concluded between the event and the product.However, since there is no information regarding the technique of injection, the conditions under which the patient received the injections and severity of the underlying osteoarthritis, a comprehensive case assessment is difficult.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5549698
• MDR Text Key: 41940975
• Report Number: 2246315-2016-00059
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SUPRAX(PREV.)
• Patient Outcome(s): Other
• Patient Age: 72 YR