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

Lot Number UNKNOWN

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

Patient Problems Cyst(s) (1800); Pain (1994); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment 27-nov-2019.This case concerns a patient who received treatment with synvisc one and later had difficulty in walk due to the pain in the tendons and had to use a cane.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

Difficult to walk due to pain in tendons [tendon pain].Difficult to walk due to pain in tendons [walking difficulty].Bakers cyst to the right knee grew 50% in size since the injection/came back to size of half of a golf ball [baker's cyst] ([condition aggravated]).Since the synvisc one he had no change in the osteoarthritis pain to the right knee [therapeutic response decreased].Knee was not aspirated on the day of injection [wrong injection technique].Case narrative: initial information received on 25-nov-2019 from united states regarding an unsolicited valid serious case received from a patient.This case involves a (b)(6) male patient who experienced difficult to walk due to pain in tendons (walking difficulty and pain upon movement) (latency: unknown), bakers cyst to the right knee grew 50% in size since the injection/came back to size of half of a golf ball (latency: unknown), since the synvisc one he had no change in the osteoarthritis pain to the right knee (latency: unknown) and knee was not aspirated on the day of injection (latency: same day), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included bakers cyst that was drained in (b)(6) 2019, pain from osteoarthritis with going up and down stairs and problems with the right knee.The patient was given a cortisone injection and the cyst was drained from the back of his knee.At the time of the event, the patient had ongoing bakers cyst.It was reported that the patient felt great after its removal, but still had pain from his osteoarthritis while going up and down the stairs and the pain happened with or without the cyst.The patient mentioned that he had problems with his right knee for many years.The past vaccination(s), concomitant medication(s) and family history were not provided.It was reported that the practitioner made a decision based off the imaging, which revealed a small amount of fluid in the knee and there was hardly any fluid, therefore, the patients knee was not aspirated on (b)(6) 2019.On the same day, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in his right knee, at dosage 6ml, frequency once (batch: unknown) (information for batch number was requested) for osteoarthritis.At the time of injection, cyst was small but could be felt.It was reported that patient had no swelling and heat after the injection but in a week the bakers cyst to the right knee grew 50% in size since the injection (latency: few days, onset date: (b)(6) 2019) i.E.Came back to size of half of a golf ball.The patient reporter that currently the cyst was not as big but it was difficult to walk due to pain in tendons (latency: unknown) and he had to use a cane since receiving hylan g-f 20, sodium hyaluronate.This event was assessed as serious and was leading to disability.It was reported that the patient did not get any bad reaction i.E.The listed side effects but had no change in the osteoarthritis pain to the right knee (latency: unknown, onset date: (b)(6) 2019).The patient was concerned if there could be a problem in the bakers cyst could due to buildup of pressure in the knee after the injection.The patient inquired if his practitioner should have drained his bakers cyst and drained his knee prior to injecting him hylan g-f 20, sodium hyaluronate.Action taken: not applicable.Corrective treatment: cane for difficult to walk due to pain in tendons; not reported for rest.Outcome: not applicable for since the synvisc one he had no change in the osteoarthritis pain to the right knee and knee was not aspirated on the day of injection; not recovered/not resolved for rest of the events.A product technical complaint was initiated and results were pending for the same.

Event Description

Difficult to walk due to pain in tendons [tendon pain] , difficult to walk due to pain in tendons [walking difficulty] , bakers cyst to the right knee grew 50% in size since the injection/came back to size of half of a golf ball [baker's cyst] ([condition aggravated]), since the synvisc one he had no change in the osteoarthritis pain to the right knee [therapeutic response decreased] , knee was not aspirated on the day of injection [wrong injection technique].Case narrative: initial information received on 25-nov-2019 from united states regarding an unsolicited valid serious case received from a patient.This case involves a 71 years old male patient who experienced difficult to walk due to pain in tendons (walking difficulty and pain upon movement) (latency: unknown), bakers cyst to the right knee grew 50% in size since the injection/came back to size of half of a golf ball (latency: unknown), since the synvisc one he had no change in the osteoarthritis pain to the right knee (latency: unknown) and knee was not aspirated on the day of injection (latency: same day), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included bakers cyst that was drained in (b)(6) 2019, pain from osteoarthritis with going up and down stairs and problems with the right knee.The patient was given a cortisone injection and the cyst was drained from the back of his knee.At the time of the event, the patient had ongoing bakers cyst.It was reported that the patient felt great after its removal, but still had pain from his osteoarthritis while going up and down the stairs and the pain happened with or without the cyst.The patient mentioned that he had problems with his right knee for many years.The past vaccination(s), concomitant medication(s) and family history were not provided it was reported that the practitioner made a decision based off the imaging, which revealed a small amount of fluid in the knee and there was hardly any fluid, therefore, the patients knee was not aspirated on (b)(6) 2019.On the same day, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in his right knee, at dosage 6ml (strength 48 mg), frequency once (batch: unknown) (information for batch number was requested) for osteoarthritis.At the time of injection, cyst was small but could be felt.It was reported that patient had no swelling and heat after the injection but in a week the bakers cyst to the right knee grew 50% in size since the injection (latency: few days, onset date: (b)(6) 2019) i.E.Came back to size of half of a golf ball.The patient reporter that currently the cyst was not as big but it was difficult to walk due to pain in tendons (latency: unknown) and he had to use a cane since receiving hylan g-f 20, sodium hyaluronate.This event was assessed as serious and was leading to disability.It was reported that the patient did not get any bad reaction i.E.The listed side effects but had no change in the osteoarthritis pain to the right knee (latency: unknown, onset date: (b)(6) 2019).The patient was concerned if there could be a problem in the bakers cyst could due to buildup of pressure in the knee after the injection.The patient inquired if his practitioner should have drained his bakers cyst and drained his knee prior to injecting him hylan g-f 20, sodium hyaluronate.Action taken: not applicable for all events.Corrective treatment: cane for difficult to walk due to pain in tendons; not reported for rest of the events.Outcome: not applicable for since the synvisc one he had no change in the osteoarthritis pain to the right knee and knee was not aspirated on the day of injection; not recovered/not resolved for rest of the events.A product technical complaint (ptc) was initiated on 26-nov-2019 for synvisc one.Batch number; unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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 is required.Final investigation complete date: 10-dec-2019 follow-up information was received on 25-nov-2019.Strength of suspect added.No significant information was received.Follow up information received on 03-dec-2019 from patient.No new information.Follow up information received on 04-dec-2019.Complaint status in process.No significant information received.Follow up information received on 03-dec-2019 from patient.No new information.Additional information was received on 10-dec-2019.Global ptc number and its results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9458672
• MDR Text Key: 186814415
• Report Number: 2246315-2019-00309
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability